0A4F4F9BD490A749D5437F821CF06DF1
Manual for Submission of “Drug Clinical Development Dossier” (DDCM) (2017)
http://portal.anvisa.gov.br/documents/33836/2492465/Manual+para+Submiss%C3%A3o+de+Dossi%C3%AA+de+Desenvolvimento+Cl%C3%ADnico+de+Medicamento+%28DDCM%29+e+Dossi%C3%AA+Espec%C3%ADfico+de+Ensaio+Cl%C3%ADnico+-+3%C2%AA+edi%C3%A7%C3%A3o/29e9c5b1-2942-4bb9-a4dd-4fccc6fccda3
http://leaux.net/URLS/ConvertAPI Text Files/99E4F74406BED57C1FEB38131C297C22.en.txt
Examining the file media/Synopses/99E4F74406BED57C1FEB38131C297C22.html:
This file was generated: 2020-07-15 04:01:45
| Indicators in focus are typically shown highlighted in yellow; |
Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink; |
"Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green; |
Trigger Words/Phrases are shown highlighted in gray. |
Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)
Applicable Type / Vulnerability / Indicator Overlay for this Input
Health / Drug Usage
Searching for indicator drug:
(return to top)
p.002017: MEDICINE (DDCM) AND SPECIFIC DOSAGE FOR CLINICAL TESTING
p.002017: MANUAL FOR SUBMISSION OF DOSSIER OF
p.002017: CLINICAL MEDICINE DEVELOPMENT (DDCM) AND SPECIFIC CLINICAL TRIAL DOSSIER
p.002017: This Manual aims to guide professionals in the area with information on how to apply Resolution RDC / Anvisa nº 09
p.002017: February 20, 2015, contributing to the development of safe actions, in addition to providing
p.002017: relevant and updated information that can be better clarified through the Manual instrument.
p.002017: The Manual does not create new obligations and should be used by public and private agents as
p.002017: reference for compliance with existing legislation.
p.000002: 2
p.000002: MANUAL FOR SUBMISSION OF CLINICAL DEVELOPMENT DOSSIER
p.000002: MEDICINE (DDCM) AND SPECIFIC DOSAGE FOR CLINICAL TESTING
p.000002: Copyright © 2017 Anvisa Copyright © 2017 Contributor
p.000002: Total or partial reproduction of this work is allowed, provided the source is mentioned.
p.000002: Edition: 3rd edition Organization - Anvisa
p.000002: General Management of Medicines
p.000002: Technical Review - Anvisa
p.000002: Adriane Alves de Oliveira
p.000002: André Luís Carvalho Santos Souza Bruno de Paula Coutinho
p.000002: Bruno Zago Franca Diniz Candida Luci Pessoa and Silva Carla Abrahao Brichesi
p.000002: Carlos Augusto Martins Netto Carolina Pingret Cintra Claudio Nishizawa
p.000002: Fanny Nascimento Moura Viana Fernando Casseb Flosi
p.000002: Flávia Regina Souza Sobral Janaina Lopes Domingos Kellen from Rocio Malaman Leonardo Fabio Costa Filho Miriam Motizuki
p.000002: Onishi Patrícia Ferrari Andreotti Ricardo Eccard da Silva Sônia Costa e Silva
p.000002: Layout and Review
p.000002: Anvisa Publisher
p.000002: Graphic project
p.000002: Anvisa Publisher
p.000002: Catalog Card:
p.000002: Manual for Clinical Drug Development Dossier (DDCM) and Specific Clinical Trial Dossier
p.000002: / Brasília. Anvisa 2017
p.000002: 27 p.
p.000002: DDCM; Specific Dossier; Clinical Trials.
p.000003: 3
p.000003: MANUAL FOR SUBMISSION OF CLINICAL DEVELOPMENT DOSSIER
p.000003: MEDICINE (DDCM) AND SPECIFIC DOSAGE FOR CLINICAL TESTING
p.000003: SUMMARY
p.000003: 1. SIGLARY
p.000005: 5
p.000005: 2. INTRODUCTION
p.000005: 5
p.000005: 3. LEGAL BASIS
p.000005: 5
p.000005: 4. OBJECTIVE
p.000005: 5
p.000005: 5. SUBMISSION OF DDCM AND SPECIFIC DOSSIERS FOR EACH CLINICAL TRIAL 6
p.000005: 5.1 DDCM SUBMISSION
p.000006: 6
p.000006: 5.2 SUBMISSION OF SPECIFIC DOSSIERS FOR EACH CLINICAL TRIAL 8
p.000006: 6. DDCM DOCUMENTS
p.000010: 10
p.000010: 6.1 MEDICINE DEVELOPMENT PLAN 10
p.000010: 6.2 RESEARCHER BROCHURE
p.000011: 11
p.000011: 6.2 DOSAGE FOR EXPERIMENTAL MEDICINE 12
p.000011: 7. ISSUE OF THE SPECIAL COMMUNICATE (EC) AND DOCUMENT FOR IMPORTING PRODUCT (S) UNDER INVESTIGATION OF THE DOSSIER OF
p.000011: CLINICAL MEDICINE DEVELOPMENT (DDCM)
p.000014: 14
p.000014: 8. SECONDARY PETITIONS
p.000015: 15
p.000015: 9. GLOSSARY
p.000016: 16
p.000016: 10. BIBLIOGRAPHIC REFERENCES
p.000019: 19
p.000019: 11. HISTORY OF CHANGES
p.000020: 20
p.000020: ANNEX I: Model of development plan
p.000022: 22
p.000004: 4
p.000004: MANUAL FOR SUBMISSION OF CLINICAL DEVELOPMENT DOSSIER
p.000004: MEDICINE (DDCM) AND SPECIFIC DOSAGE FOR CLINICAL TESTING
p.000004: 1. SIGLARY
p.000004: ATCC - Anatomical Therapeutic Chemical Code BI - Researcher's Brochure
p.000004: CE - Special Announcement
p.000004: DDCM - IFA Medicines Development Dossier - Active Pharmaceutical Ingredient
p.000004: ORPC - Representative Organization of Clinical Research RDC - Resolution of the Collegiate Board
p.000004: 2. INTRODUCTION
p.000004: The publication of the regulation on Clinical Trials with medicines in Brazil starts to evaluate Health Plans
p.000004: Development and not just isolated protocols. This manual is intended to provide
p.000004: guidelines for the sponsor, researcher-sponsor or ORPC to submit Development Dossiers
p.000004: Medicines Clinician (DDCM) and Specific Clinical Trial Dossiers in an appropriate manner.
p.000004: This is a non-binding regulatory measure adopted as a complement to legislation
p.000004: health, with the educational purpose of providing guidance on routines and procedures for compliance with
p.000004: legislation, not intended to expand or restrict established technical or administrative requirements.
p.000004: 3. LEGAL BASIS
p.000004: Anvisa Resolution - RDC nº 9, of February 20, 2015, which provides for the regulation for the
p.000004: conducting clinical trials with medicines in Brazil.
p.000004: 4. OBJECTIVE
p.000004: Without prejudice to the existing provisions in the legal provisions, this manual aims to guide and
p.000004: explain in a complementary way the submissions of Clinical Drug Development Dossiers (DDCM) and
p.000004: Specific Clinical Trial Dossiers, as described in chapter III of RDC No. 09/2015.
p.000004: We recommend that the format be standardized in terms of order and content to facilitate evaluation.
p.000005: 5
p.000005: MANUAL FOR SUBMISSION OF CLINICAL DEVELOPMENT DOSSIER
p.000005: MEDICINE (DDCM) AND SPECIFIC DOSAGE FOR CLINICAL TESTING
p.000005: 5. SUBMISSION OF DDCM AND SPECIFIC DOSSIERS FOR EACH CLINICAL TRIAL
p.000005: 5.1 DDCM SUBMISSION
p.000005: According to RDC No. 09/2015, the Clinical Drug Development Dossier (DDCM) is the
p.000005: compiled from documents to be submitted to Anvisa in order to evaluate the steps inherent to the development
p.000005: of an experimental drug in order to obtain information to support the registration or
p.000005: post-registration changes to that product.
p.000005: For the electronic petition of a DDCM at Anvisa, the regulated sector must inform one of the following
p.000005: primary petition matters:
p.000005: • 10750 - CLINICAL TRIALS - Consent in Process of the Clinical Development Dossier
p.000005: Medicines (DDCM) - Synthetics
p.000005: • 10754 - CLINICAL TRIALS - Consent in Process of the Clinical Development Dossier
p.000005: de Medicament (DDCM) - Biological Products
p.000005: • 10752 - CLINICAL TRIALS - Consent in Process of the Clinical Development Dossier
p.000005: Medicines (DDCM) - Phytotherapics
p.000005: • 10748 - CLINICAL TRIALS - Consent in Process of the Clinical Development Dossier
p.000005: of Medicines (DDCM) - Radiopharmaceuticals
p.000005: • 10751 - CLINICAL TRIALS - Consent in Process of the Clinical Development Dossier
p.000005: of Medicines (DDCM) of ORPC`s - Synthetics
p.000005: • 10755 - CLINICAL TRIALS - Consent in Process of the Development Dossier
p.000005: ORPC`s Medication Clinic (DDCM) - Biological Products
p.000005: • 10753 - CLINICAL TRIALS - Consent in Process of the Clinical Development Dossier
p.000005: of Medicines (DDCM) of ORPC`s - Phytotherapics
p.000005: • 10749 - CLINICAL TRIALS - Consent in process of the Clinical Development Dossier
p.000005: of Medicines (DDCM) of ORPC`s - Radiopharmaceuticals
p.000005: The specific check-list for the subjects mentioned above can be consulted on Anvisa's website and these
p.000005: strictly follow the description of the items contained in the standard.
p.000005: The applicant must submit a DDCM to Anvisa only in the case where it intends to conduct clinical trials with
p.000005: medicines in national territory. DDCM applies
p.000006: 6
p.000006: MANUAL FOR SUBMISSION OF CLINICAL DEVELOPMENT DOSSIER
p.000006: MEDICINE (DDCM) AND SPECIFIC DOSAGE FOR CLINICAL TESTING
p.000006: only to the development of an experimental medicine. For DDCM analysis purposes, it must be filed by the
p.000006: least one specific clinical trial dossier to be carried out in Brazil.
p.000006: At the time of electronic petition of one of the DDCM matters, the applicant must
p.000006: answer the following question: “Are there consent procedures filed with Anvisa to be
p.000006: linked to DDCM? ”. If so, the person responsible for petitioning must inform the
p.000006: case numbers of consent issues related to the DDCM experimental drug,
p.000006: already requested at Anvisa (these may have already been analyzed, approved, rejected,
p.000006: canceled, are in demand or awaiting technical analysis), which are part of the Development Plan
p.000006: product. Therefore, the consent processes already submitted to Anvisa must be linked to a
p.000006: single DDCM per experimental drug.
p.000006: The following subjects previously requested by Anvisa may be linked to a DDCM:
p.000006: • 10482 - CLINICAL TRIALS - Clinical Research Process Consent - Synthetic Drugs
p.000006: • 10479 - CLINICAL TRIALS - Consent to Clinical Research Process - Biological Products
p.000006: • 10476 - CLINICAL TRIALS - Consent in Clinical Research Process - Phytotherapics
p.000006: • 10483 - CLINICAL TRIALS - Consent in ORPC’s Clinical Research Process - Synthetic Drugs
p.000006: • 10478 - CLINICAL TRIALS - Consent to ORPC’s Clinical Research Process - Biological Products
p.000006: • 10477 - CLINICAL TRIALS - Consent in ORPC’s Clinical Research Process - Phytotherapics
p.000006: • 102 - CLINICAL TRIALS - Clinical Research Process Consent - Medicines
p.000006: • 1650 - CLINICAL TRIALS - Consent to the ORPC's Clinical Research Process - Medicines
p.000006: • 550- CLINICAL TRIALS - Notification in Clinical Research - Phase IV / Observational
p.000006: linked to DDCM
p.000006: The documents of a DDCM must be filed manually, at Anvisa, according to a specific check-list for
p.000006: the matter in question, except the Dossier (s)
p.000007: 7
p.000007: MANUAL FOR SUBMISSION OF CLINICAL DEVELOPMENT DOSSIER
p.000007: MEDICINE (DDCM) AND SPECIFIC DOSAGE FOR CLINICAL TESTING
p.000007: Specific (s) for each Clinical Trial that will be a new process, petitioned and filed
p.000007: electronics.
p.000007: 5.2 SUBMISSION OF SPECIFIC DOSSIERS FOR EACH CLINICAL TRIAL
...
p.000008: the protocol is identified as "Protocol".
p.000008: For the application process to continue, each attached file must be viewed. After
p.000008: Upon completion of the petition, a transaction number is generated. In cases of fee collection, it is not
p.000008: It is not possible to make any changes to the dossier submitted after the payment of the fee has been made. Any
p.000008: subsequent changes can be made using a specific subject code.
p.000008: It should be noted that only dossiers for clinical trials to be carried out in Brazil should be requested. Only
p.000008: dossiers that already have a clinical and non-clinical basis must be filed to be initiated,
p.000008: therefore, the CE issued for DDCM, will only contain clinical trials that Anvisa considers subject to
p.000008: initiated. If a Development Plan is presented in a complete form containing tests
p.000008: phase 1, 2 and 3 clinical trials, but studies are still being carried out in the early stages, which
p.000008: able to subsidize later phase clinical trials, the phase 3 clinical trial, for example
p.000008: example, should not be initially requested at Anvisa. This clinical trial may be requested at the
p.000008: moment when there are already sufficient clinical and non-clinical bases for its beginning. It can be
p.000008: later included as a petition on the subjects of Specific Dossiers for Clinical Trial, if not
p.000008: is different from what has already been presented in the Development Plan or with a petition for Substantial Modification of
p.000008: DDCM (10818– CLINICAL TRIALS - Modification of DDCM - Inclusion of a clinical trial protocol not provided for in the plan
p.000008: initial development) for those cases in which there is a change in the Development Plan.
p.000008: The foregoing does not apply to the Drug Development Plan (described in detail in
p.000008: section 6), where all trials planned for that experimental drug, whether they be conducted
p.000008: in Brazil or not, they must be described.
p.000009: 9
p.000009: MANUAL FOR SUBMISSION OF CLINICAL DEVELOPMENT DOSSIER
p.000009: MEDICINE (DDCM) AND SPECIFIC DOSAGE FOR CLINICAL TESTING
p.000009: 6. DDCM DOCUMENTS
p.000009: For the submission of DDCM, Section II of Chapter III of RDC nº 09/2015 must be followed. We recommend
p.000009: that all documentation be submitted in Portuguese, especially the clinical protocol and
p.000009: the researcher's brochure, as, as established in RDC 50/2013, the evaluator of the technical area may
p.000009: Exarar requirement requesting free translation of the documentation presented. Follows the description of
p.000009: some documents to facilitate DDCM submission.
p.000009: 6.1 MEDICINE DEVELOPMENT PLAN
p.000009: The development of a Development Plan by the study sponsor allows the definition of objectives and methodologies, which
p.000009: make it possible to identify critical stages and challenges of the process and plan monitoring actions, based on
p.000009: established indicators. The information available on the experimental medicinal product should support the
p.000009: proposed clinical indication, target population and types of designs proposed for clinical trials.
p.000009: The Drug Development Plan should explain the steps required for clinical investigation
p.000009: of the experimental medicine. In short, this plan must demonstrate the rationale for the development of the drug,
p.000009: predicting all the steps already executed, in progress and those intended for the clinical investigation of the drug.
p.000009: The Development Plan must also indicate the clinical trials that have been, are being or will be
p.000009: carried out outside Brazil.
p.000009: It is recommended to send a table or a schematic drawing containing all clinical trials planned for
p.000009: clinical development over a given period of time, as well as the progress of these trials
p.000009: (finalized, in progress or planned).
p.000009: The Development Plan should start with a brief description of the drug
p.000009: experimental, informing the IFA or active substance, drug category, therapeutic class, of
p.000009: according to the ATCC classification - Anatomical Therapeutic Chemical Code and route of administration. At)
p.000009: indication (s) must be technically justified by the mechanism of action of the medication
p.000009: experimental, demonstrating that it is directly or indirectly involved in the therapeutic effect or
p.000009: diagnosis. Inform, even, if the mechanism of action is innovative. In that topic should be presented (s)
p.000009: only the indication (s) proposed in the Development Plan.
p.000010: 10
p.000010: MANUAL FOR SUBMISSION OF CLINICAL DEVELOPMENT DOSSIER
p.000010: MEDICINE (DDCM) AND SPECIFIC DOSAGE FOR CLINICAL TESTING
p.000010: The sponsor must also inform the general objectives, listing all the intended indications
p.000010: for the experimental drug, even those that are not yet being investigated in the
p.000010: Development presented. A technical justification for clinical development should also be
p.000010: described. In addition, the expected duration of the proposed clinical development must be informed.
p.000010: In addition, the sponsor must provide a brief description for all clinical trials contained in the
p.000010: Development Plan, containing information about the phase, the design, the outcomes, the comparators, the
p.000010: objectives, the population to be studied, the hypothesis (s) to be tested, estimated number of participants and
p.000010: statistical planning.
p.000010: It is recommended to use the development plan template available in Annex I of this Manual.
p.000010: Anvisa recognizes that the Development Plan is not static and that it can be changed over the
p.000010: experimental drug development.
p.000010: In the Development Plan, it is not necessary to present the results of clinical trials already
p.000010: performed. The results of clinical trials should be presented in the Investigator's Brochure.
p.000010: In the case of the experimental drug already registered in Brazil, only the information that
p.000010: subsidize the proposed post-registration changes must be submitted to the Development Plan.
p.000010: 6.2 RESEARCHER BROCHURE
p.000010: The Researcher Brochure (BI) is a document that contains the compilation of non-clinical and clinical data from a
p.000010: experimental medicine that are relevant to the study in humans. Its objective is to provide
p.000010: researchers and others involved in conducting the clinical trial dose information,
p.000010: dose regimen, administration methods and security monitoring procedures. BI also
p.000010: provides support for monitoring clinical trial participants while conducting. In the meantime,
p.000010: information must be presented in a concise, clear, simple and objective language to better
p.000010: guide researchers in conducting the clinical trial.
p.000010: This item of the manual aims to explain the minimum information that must be included in a BI.
p.000010: According to the stage of development of the experimental drug and its category, the degree of
p.000010: details of available information may vary. If a drug already on the market is being
p.000010: investigated for
p.000011: 11
p.000011: MANUAL FOR SUBMISSION OF CLINICAL DEVELOPMENT DOSSIER
p.000011: MEDICINE (DDCM) AND SPECIFIC DOSAGE FOR CLINICAL TESTING
p.000011: new indication or a new population, the BI must contain information that justifies and supports this
p.000011: new condition.
p.000011: The BI must contain a brief description of the experimental drug; of the characterization
p.000011: chemistry; biological activity; formulation; characterization of the pharmacological and toxicological effects of
p.000011: experimental medicine in animals and humans, when applicable; safety and effectiveness information in
p.000011: obtained from clinical trials already carried out; as well as any critical information to
p.000011: regarding the experimental medicine. BI must present the data already known, the results available
p.000011: non-clinical and clinical studies, as well as ongoing studies and their preliminary data, when available.
p.000011: BI should explain the description of possible risks and adverse events related to the experimental drug,
p.000011: based on past experience, as well as precautions, safety alerts or special accompaniments,
p.000011: including other regulatory authorities, to be followed during development, to better guide
p.000011: the researchers who will conduct the study.
p.000011: 6.3 DOSAGE FOR EXPERIMENTAL MEDICINE
p.000011: The documents referring to items a, b, c, d, and f of the dossier of the experimental medicine described in
p.000011: RDC nº 09/2015 will be addressed in a specific guide for technical evaluation of the products under investigation.
p.000011: Thus, in this item only items g and h of Section II, of Chapter III - Content and Format will be addressed
p.000011: of Request - RDC nº 09/2015.
p.000011: The critical analysis of non-clinical studies should include the following aspects:
p.000011: I - Justify the choice of the types of tests and animal models chosen, and discuss the possible limitations
p.000011: methodologies of the tests already carried out. The tests should support the clinical indication to be studied, via
p.000011: of administration and equivalent dose in humans.
p.000011: II - Discuss the findings in animal models, with identification of the target organs and possible implications of these
p.000011: findings in humans. It must also demonstrate that the safety profile of the experimental drug, from the
p.000011: results of pharmacological and toxicological studies, is acceptable for clinical investigation.
p.000011: III - Assess the possible benefits and risks involved to support the realization of clinical development
p.000011: of the experimental medicine.
p.000012: 12
p.000012: MANUAL FOR SUBMISSION OF CLINICAL DEVELOPMENT DOSSIER
p.000012: MEDICINE (DDCM) AND SPECIFIC DOSAGE FOR CLINICAL TESTING
p.000012: IV - Present information on the locations where the studies are conducted, as well as where their records are available
p.000012: for consultation, including a statement that each study was conducted in accordance with Good
p.000012: Laboratory practices or absence justification.
p.000012: The critical analysis of clinical trials already carried out should provide for the following aspects:
p.000012: I - Discuss the scientific quality of clinical trial data based on the level of evidence and degree of
p.000012: recommendation of the available evidence. In addition, to discuss the possible methodological limitations of
p.000012: clinical trials already carried out and the procedures used to control systematic errors.
p.000012: II - Based on data from non-clinical tests, present a discussion on the monitoring of
p.000012: safety in clinical development.
p.000012: III - To substantiate the choice of safety and efficacy outcomes used in previous studies. These
p.000012: outcomes should be in line with objectives and assumptions.
p.000012: IV - In case of post-registration changes, such as, for example, increased use, new therapeutic indication,
p.000012: new pharmaceutical form or others, to base the choice of the type of design, study population, schemes
p.000012: doses and other relevant aspects related to the change.
p.000012: V - Risk management must be guided by the results of previous studies such as death or other events
p.000012: serious adverse events, type of sequelae resulting from these events, evaluations and recommendations of the Independent
p.000012: Monitoring of Safety, tolerability, toxicological findings, pharmacological safety (system
p.000012: cardiovascular, respiratory and nervous), among others. And yet, the recommendations of other agencies for the
p.000012: proposed study or experimental drug should be taken into account.
p.000012: VI - Present the assessment of the balance between the possible benefits and the risks involved for
p.000012: support the further clinical development of the experimental drug.
p.000013: 13
p.000013: MANUAL FOR SUBMISSION OF CLINICAL DEVELOPMENT DOSSIER
p.000013: MEDICINE (DDCM) AND SPECIFIC DOSAGE FOR CLINICAL TESTING
p.000013: 7. ISSUE OF THE SPECIAL COMMUNICATE (EC) AND DOCUMENT FOR IMPORTING PRODUCT (S) UNDER INVESTIGATION OF THE DOSSIER OF
p.000013: CLINICAL MEDICINE DEVELOPMENT (DDCM)
p.000013: According to RDC No. 09/2015, Special Communication (CE) is the authorizing document, issued by Anvisa,
p.000013: after analysis and approval of the DDCM, which can be used in import or export requests to a
p.000013: clinical trial. The EC describes all clinical trials authorized to be conducted in Brazil.
p.000013: Therefore, only the clinical trials listed in the EC can be started in the country, respecting the other
p.000013: ethical approvals.
p.000013: The EC also contains the list of products to be imported, referring to each clinical trial, as well as conditions
p.000013: storage and shelf life. This information is provided by the requester by
p.000013: by completing the "Clinical Trial Submission Form". If included or
p.000013: new clinical trials are excluded, products are included or excluded to be imported, or conditions are changed
p.000013: storage and expiration date, an EC update should be issued.
p.000013: Information regarding the inclusion of a Clinical Trial not provided for in the Development Plan must
p.000013: be provided to Anvisa through the subjects: 10818- CLINICAL TRIALS - DDCM Modification - Inclusion of
p.000013: clinical trial protocol not provided for in the initial development plan. In cases of inclusion
p.000013: protocol (s) already foreseen in the initial Development Plan, only submission through the
p.000013: subject (s) listed in item 5.2 of this Manual. Regarding the exclusion of protocols, the information will be provided
p.000013: through subject 10819 - CLINICAL TRIALS - DDCM modification - Exclusion of clinical trial protocol. For
p.000013: changes in information regarding the products under investigation, such as storage conditions and
p.000013: term, subject 10823 - CLINICAL TRIALS - Change of Form
p.000013: Clinical Trial Presentation. We emphasize that changes in expiration date are
p.000013: considered substantial changes and should be forwarded as explained in the Submission Manual
p.000013: Modifications, Amendments, Suspensions and Cancellations.
p.000013: For cases in which there is no manifestation by Anvisa in accordance with RDC No. 09/2015, an
p.000013: "Document for import of Product (s) under investigation of the Clinical Drug Development Dossier
p.000013: (DDCM) ”so that it is possible to import products necessary to conduct Clinical Trials. This document
p.000013: contains the same information as the CE regarding Clinical Trials and products to be imported.
p.000013: Therefore, in the case of changes to these
p.000014: 14
p.000014: MANUAL FOR SUBMISSION OF CLINICAL DEVELOPMENT DOSSIER
p.000014: MEDICINE (DDCM) AND SPECIFIC DOSAGE FOR CLINICAL TESTING
p.000014: information, the same criteria and subjects presented for EC amendments must be followed. After sending
p.000014: documentation relevant to the changes by the requester, a "Document for import will be issued
p.000014: of Product (s) under investigation by the Clinical Drug Development Dossier (DDCM) "
p.000014: updated.
p.000014: 8. SECONDARY PETITIONS
p.000014: Secondary petitions must be linked to the respective specific processes, that is, secondary petitions
p.000014: related to a DDCM should be filed with the consent process in the Dossier of
p.000014: Clinical Drug Development (DDCM). Some examples of DDCM petitions are:
p.000014: DDCM Modification, DDCM Petition Form Change, Security Update Report
p.000014: Development of Experimental Medicines, Cancellation of DDCM on Request, Global Transfer of
p.000014: DDCM Liability, Temporary DDCM Suspension, Suspended DDCM Reactivation.
p.000014: Likewise, petitions related to Clinical Trial Dossiers must be linked to the respective processes
p.000014: clinical trial. Some examples of petitions for Clinical Trial Dossiers are: Change of Form
p.000014: Presentation of Clinical Trial, Substantial Amendment to Clinical Protocol, Annual Monitoring Report
p.000014: Clinical Trial Protocol, Cancellation of Clinical Trial Protocol on Request, Global Transfer of
p.000014: Liability for Clinical Trial Protocol, Temporary Trial Trial Suspension
p.000014: Clinical, Reactivation of Suspended Clinical Trials Protocol.
p.000014: The linking of secondary petitions to the corresponding processes is fundamental for the analysis and
p.000014: traceability of these in Anvisa's electronic systems.
p.000014: Secondary petitions must be filed electronically. For each item contained in the checklist
p.000014: of these petitions it will be necessary for the applicant to attach at least one PDF file, which allows textual search.
p.000014: It will be possible to attach up to 5 files in the size of 750 Kb.
p.000014: For the application process to continue, each attached file must be viewed. After
p.000014: Upon completion of the petition, a transaction number will be generated. In cases of fee collection, it will not be possible
p.000014: make no changes to the dossier submitted after payment of the fee. Any change
p.000014: can be carried out using a specific subject code.
p.000015: 15
p.000015: MANUAL FOR SUBMISSION OF CLINICAL DEVELOPMENT DOSSIER
p.000015: MEDICINE (DDCM) AND SPECIFIC DOSAGE FOR CLINICAL TESTING
p.000015: 9. GLOSSARY
p.000015: I - Good Laboratory Practices (GLP) - quality system that encompasses the organizational process and conditions in
p.000015: which non-clinical studies related to health and safety to the environment are planned, developed,
p.000015: monitored, recorded, filed and reported;
p.000015: II - Researcher's Brochure - compiled of clinical and non-clinical data on the drug (s)
p.000015: experimental (s), which are relevant for their study in humans;
p.000015: III - Independent Security Monitoring Committee - independent committee, constituted for the
p.000015: monitoring specific safety data collected from one or more clinical trials at defined intervals.
p.000015: Recommends to the sponsor if a study should be continued, modified or interrupted;
p.000015: IV - Special Communication (CE) - an authorizing document, issued by Anvisa, after analysis and
p.000015: DDCM approval, which can be used in import or export requests for a clinical trial;
p.000015: V - Clinical Drug Development Dossier (DDCM) - compiled from documents to be submitted to the
p.000015: Anvisa in order to evaluate the steps inherent to the development of an experimental drug
p.000015: with a view to obtaining information to support the registration or post-registration changes of said
p.000015: product;
p.000015: VI - Specific Dossier for each Clinical Trial - compiled from documents to be submitted to Anvisa with the
p.000015: purpose of obtaining information regarding clinical trials, to be conducted in Brazil, which are part of the
p.000015: Experimental Drug Development Plan;
p.000015: VI - Document for the Importation of Product (s) under investigation by the Clinical Development Dossier of
p.000015: Medication (DDCM): Document issued by Anvisa, necessary for the import or export request for
p.000015: a clinical trial, in cases of non-manifestation about DDCM;
p.000015: VII - Amendment to the clinical trial protocol - any proposed modification to a clinical trial protocol
p.000015: original, always presented with the justification that motivated it, and this amendment may be substantial or not;
p.000015: VIII - Clinical trial - research conducted on human beings with the objective of discovering or confirming the
p.000015: clinical and / or pharmacological effects and / or any other pharmacodynamic effect of the medicinal product
p.000015: experimental and / or identify any adverse reaction to the experimental drug and / or study absorption,
p.000015: distribution, metabolism and excretion of the experimental drug to verify its safety and / or effectiveness;
p.000016: 16
p.000016: MANUAL FOR SUBMISSION OF CLINICAL DEVELOPMENT DOSSIER
p.000016: MEDICINE (DDCM) AND SPECIFIC DOSAGE FOR CLINICAL TESTING
p.000016: IX - Active Pharmaceutical Ingredient (IFA) - any substance introduced in the formulation of a pharmaceutical form that,
p.000016: when administered to a patient, it acts as an active ingredient. Such substances can exert activity
p.000016: pharmacological or other direct effect in the diagnosis, cure, treatment or prevention of a disease,
p.000016: affect the structure and functioning of the human organism;
p.000016: X - Investigator - person responsible for conducting a clinical trial at the site where the trial is conducted. If
p.000016: the study is conducted by a group of people, the researcher is the leader of the group and will be called
p.000016: principal investigator;
p.000016: XI - Investigator-Sponsor - individual responsible for conducting and coordinating
p.000016: clinical trials, alone or in a group, carried out under its immediate direction independently,
p.000016: developed with financial and material resources of the researcher, from national or international
p.000016: international research, private and non-profit entities;
p.000016: XII - Experimental medicine - pharmaceutical product under test, object of DDCM, to be used in the clinical trial,
p.000016: for the purpose of obtaining information for your registration or post-registration;
p.000016: XIII - Representative Organization for Clinical Research (ORPC) - every company regularly installed
p.000016: in national territory hired by the sponsor or by the researcher-sponsor, who assumes partial
p.000016: or totally, with Anvisa, the sponsor's duties;
p.000016: XIV - Sponsor - person, company, institution or organization responsible for initiating, managing,
p.000016: control and / or finance a clinical study;
p.000016: XV - Placebo - formulation without pharmacological effect, administered to the participant of the clinical trial for the purpose of
p.000016: masking or comparator;
p.000016: XVI - Product under investigation - experimental drug, placebo, active comparator or any other product
p.000016: to be used in the clinical trial;
p.000016: XVII - Clinical Trial Protocol - document that describes the objectives, design, methodology,
p.000016: statistical considerations and trial organization. It also provides the context and rationale for the essay
p.000016: clinical;
p.000016: XVIII - Annual Monitoring Report - annual document containing specific information
p.000016: on the conduct of a specific clinical trial in centers in Brazil, according to the clinical protocol and the BPC;
p.000016: XIX - Safety update report for experimental drug development - report
p.000016: harmonized periodical containing safety information and development of an experimental drug;
p.000017: 17
p.000017: MANUAL FOR SUBMISSION OF CLINICAL DEVELOPMENT DOSSIER
p.000017: MEDICINE (DDCM) AND SPECIFIC DOSAGE FOR CLINICAL TESTING
p.000017: XX - Active substance - is the substance with pharmacological effect for the intended therapeutic activity,
p.000017: used in the production of a given biological product.
p.000018: 18
p.000018: MANUAL FOR SUBMISSION OF CLINICAL DEVELOPMENT DOSSIER
p.000018: MEDICINE (DDCM) AND SPECIFIC DOSAGE FOR CLINICAL TESTING
p.000018: 10. BIBLIOGRAPHIC REFERENCES
p.000018: 1. BRAZIL. ANVISA. National Health Surveillance Agency. RDC Resolution No. 09, of February 20, 2015, published
p.000018: in the D.O.U. March 3, 2015. Deals with the regulation for conducting clinical trials with drugs in the
p.000018: Brazil. Official Diary of the Union; Executive Branch, of March 3, 2015.
p.000018: 2. GUIDELINE FOR GOOD CLINICAL PRACTICE. ICH E6 (R1). Available in:
p.000018: p.000018: /E6_R1_Guideline.pdf> Accessed on: 02 sep. 2016.
p.000019: 19
p.000019: MANUAL FOR SUBMISSION OF CLINICAL DEVELOPMENT DOSSIER
p.000019: MEDICINE (DDCM) AND SPECIFIC DOSAGE FOR CLINICAL TESTING
p.000019: 11. HISTORY OF CHANGES
p.000019: Version
p.000019: Changes made
p.000019: Explanation and Justification
p.000019: 1st edition ---
p.000019: 2nd Edition
p.000019: 2nd Edition
p.000019: • Replacement in the entire document of "Resolution that provides for the Sanitary Regulation for carrying out
p.000019: clinical trials with medicines in Brazil "by" RDC nº 09/2015 "
...
p.000020: 3rd Edition
p.000020: 3rd Edition
p.000020: technical justification for clinical development should also be described. ”
p.000020: • Inclusion of the following paragraph in item 6.1: “It is recommended to use the development plan model
p.000020: available in Annex I of this Manual. ”
p.000020: • Alteration of item “6.2. Experimental Medication Dossier ”for item 6.3
p.000020: • Inclusion of Annex I
p.000020: clinical development.
p.000020: • Due to several problems identified in development plans evaluated so far, COPEC
p.000020: developed a model plan to facilitate analysis of the document by Anvisa.
p.000020: • Numbering correction
p.000020: • Provision of a development plan model to facilitate the analysis of the document by Anvisa
p.000021: 21
p.000021: MANUAL FOR SUBMISSION OF CLINICAL DEVELOPMENT DOSSIER
p.000021: MEDICINE (DDCM) AND SPECIFIC DOSAGE FOR CLINICAL TESTING
p.000021: ANNEX I: Model of development plan
p.000021: MODELOv1 - Development Plan - Medicament XXX - Version XX of xx / xx / xxxx
p.000021: Sponsor: XXXXX
p.000021: 1) IFA or active substance
p.000021: Give a brief description of the IFA or active substance. For example: IFA name, physicochemical characteristics and
p.000021: biological.
p.000021: 2) Category of medication
p.000021: Inform whether the medicine is synthetic, biological, herbal or radiopharmaceutical
p.000021: 3) Therapeutic class
p.000021: Inform the therapeutic class of the medication
p.000021: 4) Route of administration
p.000021: Inform the studied and intended routes of administration
p.000021: In this item, one can also inform the pharmaceutical forms and dosages of the experimental drug. For example:
p.000021: 10 mg coated tablet for oral administration and granules for oral suspension of 5 mg.
p.000021: 5) Mechanism of action
p.000021: Briefly inform the mechanism of action and explain whether the mechanism is innovative. Submit a technical justification for
p.000021: this clinical development of this medicine.
p.000021: 6) Indications to be studied
p.000021: Inform the therapeutic indications of the experimental drug that have been studied and those that are intended to be evaluated
p.000021: in this clinical development.
p.000021: 7) General objectives and the planned duration for clinical development
p.000021: Inform the general objectives of clinical development and send a technical justification for this development
p.000021: clinical characteristics of this
p.000021: Inform the expected duration of development. For example: The estimated duration of clinical development is
p.000021: expected in 2025.
p.000021: In this section, you can also be informed if the medication has already been sent to the registration area
p.000021: Anvisa and for which indications / pharmaceutical forms / populations.
p.000022: 22
p.000022: MANUAL FOR SUBMISSION OF CLINICAL DEVELOPMENT DOSSIER
p.000022: MEDICINE (DDCM) AND SPECIFIC DOSAGE FOR CLINICAL TESTING
p.000022: In this section, it can also be informed if the experimental drug has already been submitted for registration in
p.000022: other countries and awaits a response from other agencies. In this case, inform
p.000022: for which indications / pharmaceutical forms / populations the registration was submitted.
p.000022: 8) Clinical trials
p.000022: 8.1. List of completed, ongoing, and planned clinical trials
p.000022: Protocol
p.000022: THE
p.000022: Status
p.000022: Finished
p.000022: Start
p.000022: 01/01/2010
p.000022: End
p.000022: 12/20/2010
p.000022: Phase
p.000001: 1
p.000001: Number of participants 30
p.000001: Participation of Brazil
p.000001: Not
p.000001: Fill:
p.000001: • Protocol: inform the protocol code
p.000001: • Status: inform if the study has been completed, is in progress or is planned
p.000001: • Start: inform the date the study was started. If it is a planned study, place the forecast for the start of the
p.000001: clinical trial
p.000001: • End: inform the date that the study was completed. If it is a planned study, put the closure forecast
p.000001: clinical trial
p.000001: • Phase: inform if it is phase 1, 2, 3, etc.
p.000001: • Participation by Brazil: inform if the study was / is being / will be conducted in Brazil
p.000001: 8.2. Description of clinical trials
p.000001: 8.2.1. Clinical trials completed or in progress
p.000001: Planned clinical trial Participation of Centers in Brazil
p.000001: Estimated number of participants
p.000001: Status Phase Drawing
p.000001: Objectives Outcomes
p.000001: Protocol code:
p.000001: Yes No ( )
p.000001: Finished () In progress ()
p.000023: 23
p.000023: MANUAL FOR SUBMISSION OF CLINICAL DEVELOPMENT DOSSIER
p.000023: MEDICINE (DDCM) AND SPECIFIC DOSAGE FOR CLINICAL TESTING
p.000023: Comparators
p.000023: Posology of the experimental drug
p.000023: Comparator dosage
p.000023: Pharmaceutical form of the experimental drug Population
p.000023: Note: If there is a clinical trial that is in progress outside of Brazil, but that is planned to be
p.000023: conducted in Brazil, include the study in “planned clinical trials”.
p.000023: 8.2.2. Planned clinical trials
p.000023: 8.2.2.1. Clinical trial A
p.000023: Planned clinical trial Participation of Centers in Brazil
p.000023: Estimated number of participants
p.000023: Status
p.000023: Design Phase Objectives Outcomes
p.000023: Comparators
p.000023: Posology of the experimental drug
p.000023: Comparator dosage
p.000023: Pharmaceutical form of the experimental drug Population
p.000023: Hypothesis
p.000023: Statistical planning
p.000023: Protocol code: Yes () No ()
p.000023: Global Start Forecast: Brazil Start Forecast: End Forecast:
p.000023: 8.2.2.2 Clinical Trial B
p.000023: Planned clinical trial Participation of Centers in Brazil
p.000023: Estimated amount of
p.000023: Protocol code: Yes () No ()
p.000024: 24
p.000024: MANUAL FOR SUBMISSION OF CLINICAL DEVELOPMENT DOSSIER
p.000024: MEDICINE (DDCM) AND SPECIFIC DOSAGE FOR CLINICAL TESTING
p.000024: Status participants
p.000024: Design Phase Objectives Outcomes
p.000024: Comparators
p.000024: Posology of the experimental drug
p.000024: Comparator dosage
p.000024: Pharmaceutical form of the experimental drug Population
p.000024: Hypothesis
p.000024: Statistical planning
p.000024: Global Start Forecast: Brazil Start Forecast: End Forecast:
p.000024: 8.2.2.3 Clinical Trial C
p.000024: Planned clinical trial Participation of Centers in Brazil
p.000024: Estimated number of participants
p.000024: Status
p.000024: Design Phase Objectives Outcomes
p.000024: Comparators
p.000024: Posology of the experimental drug
p.000024: Comparator dosage
p.000024: Pharmaceutical form of the experimental drug Population
p.000024: Hypothesis
p.000024: Statistical planning
p.000024: Protocol code: Yes () No ()
p.000024: Global Start Forecast: Brazil Start Forecast: End Forecast:
p.000025: 25
p.000025: MANUAL FOR SUBMISSION OF CLINICAL DEVELOPMENT DOSSIER
p.000025: MEDICINE (DDCM) AND SPECIFIC DOSAGE FOR CLINICAL TESTING
p.000025: Fill:
p.000025: • Planned clinical trial: inform the protocol code
p.000025: • Participation of centers in Brazil: answer whether or not the participation of Brazil is foreseen in this
p.000025: clinical trial
p.000025: • Estimated number of participants: inform the number of participants expected in the study
p.000025: • Status: inform the expected date for the study to start in Brazil and in the world (if applicable) and the
p.000025: end forecast
p.000025: • Phase: inform if it is phase 1, 2, 3, etc.
p.000025: • Design: the title of the study can be informed
p.000025: • Objective: include at least the primary and secondary objectives
p.000025: • Outcome: include at least the outcomes for primary and secondary objectives
p.000025: • Comparator: inform the name of the active comparator or indicate whether it is placebo (or placebo + basic therapy) and justify
p.000025: the rationale for choosing the comparator. In the case of open studies, justify the rationale.
p.000025: • Posology of the experimental drug: inform the dose and treatment schedule
p.000025: • Posology of comparators: inform the dose and treatment schedule
...
...
Searching for indicator substance:
(return to top)
p.000009: some documents to facilitate DDCM submission.
p.000009: 6.1 MEDICINE DEVELOPMENT PLAN
p.000009: The development of a Development Plan by the study sponsor allows the definition of objectives and methodologies, which
p.000009: make it possible to identify critical stages and challenges of the process and plan monitoring actions, based on
p.000009: established indicators. The information available on the experimental medicinal product should support the
p.000009: proposed clinical indication, target population and types of designs proposed for clinical trials.
p.000009: The Drug Development Plan should explain the steps required for clinical investigation
p.000009: of the experimental medicine. In short, this plan must demonstrate the rationale for the development of the drug,
p.000009: predicting all the steps already executed, in progress and those intended for the clinical investigation of the drug.
p.000009: The Development Plan must also indicate the clinical trials that have been, are being or will be
p.000009: carried out outside Brazil.
p.000009: It is recommended to send a table or a schematic drawing containing all clinical trials planned for
p.000009: clinical development over a given period of time, as well as the progress of these trials
p.000009: (finalized, in progress or planned).
p.000009: The Development Plan should start with a brief description of the drug
p.000009: experimental, informing the IFA or active substance, drug category, therapeutic class, of
p.000009: according to the ATCC classification - Anatomical Therapeutic Chemical Code and route of administration. At)
p.000009: indication (s) must be technically justified by the mechanism of action of the medication
p.000009: experimental, demonstrating that it is directly or indirectly involved in the therapeutic effect or
p.000009: diagnosis. Inform, even, if the mechanism of action is innovative. In that topic should be presented (s)
p.000009: only the indication (s) proposed in the Development Plan.
p.000010: 10
p.000010: MANUAL FOR SUBMISSION OF CLINICAL DEVELOPMENT DOSSIER
p.000010: MEDICINE (DDCM) AND SPECIFIC DOSAGE FOR CLINICAL TESTING
p.000010: The sponsor must also inform the general objectives, listing all the intended indications
p.000010: for the experimental drug, even those that are not yet being investigated in the
p.000010: Development presented. A technical justification for clinical development should also be
p.000010: described. In addition, the expected duration of the proposed clinical development must be informed.
p.000010: In addition, the sponsor must provide a brief description for all clinical trials contained in the
p.000010: Development Plan, containing information about the phase, the design, the outcomes, the comparators, the
p.000010: objectives, the population to be studied, the hypothesis (s) to be tested, estimated number of participants and
p.000010: statistical planning.
p.000010: It is recommended to use the development plan template available in Annex I of this Manual.
p.000010: Anvisa recognizes that the Development Plan is not static and that it can be changed over the
...
p.000015: product;
p.000015: VI - Specific Dossier for each Clinical Trial - compiled from documents to be submitted to Anvisa with the
p.000015: purpose of obtaining information regarding clinical trials, to be conducted in Brazil, which are part of the
p.000015: Experimental Drug Development Plan;
p.000015: VI - Document for the Importation of Product (s) under investigation by the Clinical Development Dossier of
p.000015: Medication (DDCM): Document issued by Anvisa, necessary for the import or export request for
p.000015: a clinical trial, in cases of non-manifestation about DDCM;
p.000015: VII - Amendment to the clinical trial protocol - any proposed modification to a clinical trial protocol
p.000015: original, always presented with the justification that motivated it, and this amendment may be substantial or not;
p.000015: VIII - Clinical trial - research conducted on human beings with the objective of discovering or confirming the
p.000015: clinical and / or pharmacological effects and / or any other pharmacodynamic effect of the medicinal product
p.000015: experimental and / or identify any adverse reaction to the experimental drug and / or study absorption,
p.000015: distribution, metabolism and excretion of the experimental drug to verify its safety and / or effectiveness;
p.000016: 16
p.000016: MANUAL FOR SUBMISSION OF CLINICAL DEVELOPMENT DOSSIER
p.000016: MEDICINE (DDCM) AND SPECIFIC DOSAGE FOR CLINICAL TESTING
p.000016: IX - Active Pharmaceutical Ingredient (IFA) - any substance introduced in the formulation of a pharmaceutical form that,
p.000016: when administered to a patient, it acts as an active ingredient. Such substances can exert activity
p.000016: pharmacological or other direct effect in the diagnosis, cure, treatment or prevention of a disease,
p.000016: affect the structure and functioning of the human organism;
p.000016: X - Investigator - person responsible for conducting a clinical trial at the site where the trial is conducted. If
p.000016: the study is conducted by a group of people, the researcher is the leader of the group and will be called
p.000016: principal investigator;
p.000016: XI - Investigator-Sponsor - individual responsible for conducting and coordinating
p.000016: clinical trials, alone or in a group, carried out under its immediate direction independently,
p.000016: developed with financial and material resources of the researcher, from national or international
p.000016: international research, private and non-profit entities;
p.000016: XII - Experimental medicine - pharmaceutical product under test, object of DDCM, to be used in the clinical trial,
p.000016: for the purpose of obtaining information for your registration or post-registration;
p.000016: XIII - Representative Organization for Clinical Research (ORPC) - every company regularly installed
p.000016: in national territory hired by the sponsor or by the researcher-sponsor, who assumes partial
p.000016: or totally, with Anvisa, the sponsor's duties;
p.000016: XIV - Sponsor - person, company, institution or organization responsible for initiating, managing,
p.000016: control and / or finance a clinical study;
p.000016: XV - Placebo - formulation without pharmacological effect, administered to the participant of the clinical trial for the purpose of
p.000016: masking or comparator;
p.000016: XVI - Product under investigation - experimental drug, placebo, active comparator or any other product
p.000016: to be used in the clinical trial;
p.000016: XVII - Clinical Trial Protocol - document that describes the objectives, design, methodology,
p.000016: statistical considerations and trial organization. It also provides the context and rationale for the essay
p.000016: clinical;
p.000016: XVIII - Annual Monitoring Report - annual document containing specific information
p.000016: on the conduct of a specific clinical trial in centers in Brazil, according to the clinical protocol and the BPC;
p.000016: XIX - Safety update report for experimental drug development - report
p.000016: harmonized periodical containing safety information and development of an experimental drug;
p.000017: 17
p.000017: MANUAL FOR SUBMISSION OF CLINICAL DEVELOPMENT DOSSIER
p.000017: MEDICINE (DDCM) AND SPECIFIC DOSAGE FOR CLINICAL TESTING
p.000017: XX - Active substance - is the substance with pharmacological effect for the intended therapeutic activity,
p.000017: used in the production of a given biological product.
p.000018: 18
p.000018: MANUAL FOR SUBMISSION OF CLINICAL DEVELOPMENT DOSSIER
p.000018: MEDICINE (DDCM) AND SPECIFIC DOSAGE FOR CLINICAL TESTING
p.000018: 10. BIBLIOGRAPHIC REFERENCES
p.000018: 1. BRAZIL. ANVISA. National Health Surveillance Agency. RDC Resolution No. 09, of February 20, 2015, published
p.000018: in the D.O.U. March 3, 2015. Deals with the regulation for conducting clinical trials with drugs in the
p.000018: Brazil. Official Diary of the Union; Executive Branch, of March 3, 2015.
p.000018: 2. GUIDELINE FOR GOOD CLINICAL PRACTICE. ICH E6 (R1). Available in:
p.000018: p.000018: /E6_R1_Guideline.pdf> Accessed on: 02 sep. 2016.
p.000019: 19
p.000019: MANUAL FOR SUBMISSION OF CLINICAL DEVELOPMENT DOSSIER
p.000019: MEDICINE (DDCM) AND SPECIFIC DOSAGE FOR CLINICAL TESTING
p.000019: 11. HISTORY OF CHANGES
p.000019: Version
p.000019: Changes made
p.000019: Explanation and Justification
p.000019: 1st edition ---
p.000019: 2nd Edition
p.000019: 2nd Edition
p.000019: • Replacement in the entire document of "Resolution that provides for the Sanitary Regulation for carrying out
p.000019: clinical trials with medicines in Brazil "by" RDC nº 09/2015 "
p.000019: • Changed the name of the petition subject to: Global Transfer of Responsibility on DDCM (page 15).
p.000019: • Since the first edition of the Submission Manual had been finalized before the publication of the new standard,
p.000019: there was also the definition of the number of the new DRC. This was corrected in this first review.
p.000019: • Changing the name of the petition subject.
p.000019: 2nd Edition
...
p.000019: • Inclusion of the following sentence in the 4th paragraph in item 6.1: “Inform, even, if the mechanism of action is innovative.”
p.000019: • Inclusion of the following sentence in the 5th paragraph in item 6.1: “A
p.000019: • With more than a year of implementation of RDC No. 09/2015, these transitional provisions have lost their objects and
p.000019: most apply.
p.000019: • Information on the innovation of the action mechanism is important to assess the rationale for development
p.000019: clinical.
p.000019: • For a better understanding of what is the technical justification for the
p.000020: 20
p.000020: MANUAL FOR SUBMISSION OF CLINICAL DEVELOPMENT DOSSIER
p.000020: MEDICINE (DDCM) AND SPECIFIC DOSAGE FOR CLINICAL TESTING
p.000020: 3rd Edition
p.000020: 3rd Edition
p.000020: 3rd Edition
p.000020: technical justification for clinical development should also be described. ”
p.000020: • Inclusion of the following paragraph in item 6.1: “It is recommended to use the development plan model
p.000020: available in Annex I of this Manual. ”
p.000020: • Alteration of item “6.2. Experimental Medication Dossier ”for item 6.3
p.000020: • Inclusion of Annex I
p.000020: clinical development.
p.000020: • Due to several problems identified in development plans evaluated so far, COPEC
p.000020: developed a model plan to facilitate analysis of the document by Anvisa.
p.000020: • Numbering correction
p.000020: • Provision of a development plan model to facilitate the analysis of the document by Anvisa
p.000021: 21
p.000021: MANUAL FOR SUBMISSION OF CLINICAL DEVELOPMENT DOSSIER
p.000021: MEDICINE (DDCM) AND SPECIFIC DOSAGE FOR CLINICAL TESTING
p.000021: ANNEX I: Model of development plan
p.000021: MODELOv1 - Development Plan - Medicament XXX - Version XX of xx / xx / xxxx
p.000021: Sponsor: XXXXX
p.000021: 1) IFA or active substance
p.000021: Give a brief description of the IFA or active substance. For example: IFA name, physicochemical characteristics and
p.000021: biological.
p.000021: 2) Category of medication
p.000021: Inform whether the medicine is synthetic, biological, herbal or radiopharmaceutical
p.000021: 3) Therapeutic class
p.000021: Inform the therapeutic class of the medication
p.000021: 4) Route of administration
p.000021: Inform the studied and intended routes of administration
p.000021: In this item, one can also inform the pharmaceutical forms and dosages of the experimental drug. For example:
p.000021: 10 mg coated tablet for oral administration and granules for oral suspension of 5 mg.
p.000021: 5) Mechanism of action
p.000021: Briefly inform the mechanism of action and explain whether the mechanism is innovative. Submit a technical justification for
p.000021: this clinical development of this medicine.
p.000021: 6) Indications to be studied
p.000021: Inform the therapeutic indications of the experimental drug that have been studied and those that are intended to be evaluated
p.000021: in this clinical development.
p.000021: 7) General objectives and the planned duration for clinical development
p.000021: Inform the general objectives of clinical development and send a technical justification for this development
p.000021: clinical characteristics of this
p.000021: Inform the expected duration of development. For example: The estimated duration of clinical development is
p.000021: expected in 2025.
p.000021: In this section, you can also be informed if the medication has already been sent to the registration area
p.000021: Anvisa and for which indications / pharmaceutical forms / populations.
p.000022: 22
p.000022: MANUAL FOR SUBMISSION OF CLINICAL DEVELOPMENT DOSSIER
...
Social / Age
Searching for indicator age:
(return to top)
p.000024: Hypothesis
p.000024: Statistical planning
p.000024: Protocol code: Yes () No ()
p.000024: Global Start Forecast: Brazil Start Forecast: End Forecast:
p.000025: 25
p.000025: MANUAL FOR SUBMISSION OF CLINICAL DEVELOPMENT DOSSIER
p.000025: MEDICINE (DDCM) AND SPECIFIC DOSAGE FOR CLINICAL TESTING
p.000025: Fill:
p.000025: • Planned clinical trial: inform the protocol code
p.000025: • Participation of centers in Brazil: answer whether or not the participation of Brazil is foreseen in this
p.000025: clinical trial
p.000025: • Estimated number of participants: inform the number of participants expected in the study
p.000025: • Status: inform the expected date for the study to start in Brazil and in the world (if applicable) and the
p.000025: end forecast
p.000025: • Phase: inform if it is phase 1, 2, 3, etc.
p.000025: • Design: the title of the study can be informed
p.000025: • Objective: include at least the primary and secondary objectives
p.000025: • Outcome: include at least the outcomes for primary and secondary objectives
p.000025: • Comparator: inform the name of the active comparator or indicate whether it is placebo (or placebo + basic therapy) and justify
p.000025: the rationale for choosing the comparator. In the case of open studies, justify the rationale.
p.000025: • Posology of the experimental drug: inform the dose and treatment schedule
p.000025: • Posology of comparators: inform the dose and treatment schedule
p.000025: • Pharmaceutical form of the experimental drug: inform the pharmaceutical form used in this clinical trial
p.000025: • Population: inform the profile of the population (age group, gender, disease, etc.)
p.000025: • Hypothesis: inform if there is a hypothesis for the clinical trial. If yes, inform the hypothesis to be tested
p.000025: • Number of participants: inform the number of participants expected or recruited in the study
p.000025: • Statistical planning: inform at least the determination of the sample size, description of the analysis of
p.000025: effectiveness and safety.
p.000025: 9) Timeline with all clinical trials of drug development.
p.000025: Example:
p.000026: 26
p.000026: MANUAL FOR SUBMISSION OF CLINICAL DEVELOPMENT DOSSIER
p.000026: MEDICINE (DDCM) AND SPECIFIC DOSAGE FOR CLINICAL TESTING
p.000026: GENERAL OBSERVATIONS:
p.000026: ✓ The plan should be written preferably in Portuguese.
p.000026: ✓ For each new plan update, change the document version, highlight the changes made and
p.000026: send a change tracking history.
p.000026: ✓ There is no need to include the results of clinical trials in this document. The results should be
p.000026: presented in the Investigator's Brochure.
p.000026: ✓ The development plan is the first technical document to be analyzed, as it provides an overview
p.000026: of the DDCM. In this way, the more complete and clear the document is, the faster the DDCM analysis will be
p.000026: as a whole. Other documents can be referenced in this document, however, the brief description of each
p.000026: item facilitates the analysis, as it allows to quickly verify the clinical development of the drug.
p.000026: ✓ It is clarified that Anvisa understands that the Development Plan is a dynamic document, which can be changed
p.000026: throughout clinical development. However, even so, such information is fundamental for a first
...
Social / Linguistic Proficiency
Searching for indicator language:
(return to top)
p.000010: In addition, the sponsor must provide a brief description for all clinical trials contained in the
p.000010: Development Plan, containing information about the phase, the design, the outcomes, the comparators, the
p.000010: objectives, the population to be studied, the hypothesis (s) to be tested, estimated number of participants and
p.000010: statistical planning.
p.000010: It is recommended to use the development plan template available in Annex I of this Manual.
p.000010: Anvisa recognizes that the Development Plan is not static and that it can be changed over the
p.000010: experimental drug development.
p.000010: In the Development Plan, it is not necessary to present the results of clinical trials already
p.000010: performed. The results of clinical trials should be presented in the Investigator's Brochure.
p.000010: In the case of the experimental drug already registered in Brazil, only the information that
p.000010: subsidize the proposed post-registration changes must be submitted to the Development Plan.
p.000010: 6.2 RESEARCHER BROCHURE
p.000010: The Researcher Brochure (BI) is a document that contains the compilation of non-clinical and clinical data from a
p.000010: experimental medicine that are relevant to the study in humans. Its objective is to provide
p.000010: researchers and others involved in conducting the clinical trial dose information,
p.000010: dose regimen, administration methods and security monitoring procedures. BI also
p.000010: provides support for monitoring clinical trial participants while conducting. In the meantime,
p.000010: information must be presented in a concise, clear, simple and objective language to better
p.000010: guide researchers in conducting the clinical trial.
p.000010: This item of the manual aims to explain the minimum information that must be included in a BI.
p.000010: According to the stage of development of the experimental drug and its category, the degree of
p.000010: details of available information may vary. If a drug already on the market is being
p.000010: investigated for
p.000011: 11
p.000011: MANUAL FOR SUBMISSION OF CLINICAL DEVELOPMENT DOSSIER
p.000011: MEDICINE (DDCM) AND SPECIFIC DOSAGE FOR CLINICAL TESTING
p.000011: new indication or a new population, the BI must contain information that justifies and supports this
p.000011: new condition.
p.000011: The BI must contain a brief description of the experimental drug; of the characterization
p.000011: chemistry; biological activity; formulation; characterization of the pharmacological and toxicological effects of
p.000011: experimental medicine in animals and humans, when applicable; safety and effectiveness information in
p.000011: obtained from clinical trials already carried out; as well as any critical information to
p.000011: regarding the experimental medicine. BI must present the data already known, the results available
p.000011: non-clinical and clinical studies, as well as ongoing studies and their preliminary data, when available.
p.000011: BI should explain the description of possible risks and adverse events related to the experimental drug,
p.000011: based on past experience, as well as precautions, safety alerts or special accompaniments,
p.000011: including other regulatory authorities, to be followed during development, to better guide
p.000011: the researchers who will conduct the study.
...
Social / Trade Union Membership
Searching for indicator union:
(return to top)
p.000016: to be used in the clinical trial;
p.000016: XVII - Clinical Trial Protocol - document that describes the objectives, design, methodology,
p.000016: statistical considerations and trial organization. It also provides the context and rationale for the essay
p.000016: clinical;
p.000016: XVIII - Annual Monitoring Report - annual document containing specific information
p.000016: on the conduct of a specific clinical trial in centers in Brazil, according to the clinical protocol and the BPC;
p.000016: XIX - Safety update report for experimental drug development - report
p.000016: harmonized periodical containing safety information and development of an experimental drug;
p.000017: 17
p.000017: MANUAL FOR SUBMISSION OF CLINICAL DEVELOPMENT DOSSIER
p.000017: MEDICINE (DDCM) AND SPECIFIC DOSAGE FOR CLINICAL TESTING
p.000017: XX - Active substance - is the substance with pharmacological effect for the intended therapeutic activity,
p.000017: used in the production of a given biological product.
p.000018: 18
p.000018: MANUAL FOR SUBMISSION OF CLINICAL DEVELOPMENT DOSSIER
p.000018: MEDICINE (DDCM) AND SPECIFIC DOSAGE FOR CLINICAL TESTING
p.000018: 10. BIBLIOGRAPHIC REFERENCES
p.000018: 1. BRAZIL. ANVISA. National Health Surveillance Agency. RDC Resolution No. 09, of February 20, 2015, published
p.000018: in the D.O.U. March 3, 2015. Deals with the regulation for conducting clinical trials with drugs in the
p.000018: Brazil. Official Diary of the Union; Executive Branch, of March 3, 2015.
p.000018: 2. GUIDELINE FOR GOOD CLINICAL PRACTICE. ICH E6 (R1). Available in:
p.000018: p.000018: /E6_R1_Guideline.pdf> Accessed on: 02 sep. 2016.
p.000019: 19
p.000019: MANUAL FOR SUBMISSION OF CLINICAL DEVELOPMENT DOSSIER
p.000019: MEDICINE (DDCM) AND SPECIFIC DOSAGE FOR CLINICAL TESTING
p.000019: 11. HISTORY OF CHANGES
p.000019: Version
p.000019: Changes made
p.000019: Explanation and Justification
p.000019: 1st edition ---
p.000019: 2nd Edition
p.000019: 2nd Edition
p.000019: • Replacement in the entire document of "Resolution that provides for the Sanitary Regulation for carrying out
p.000019: clinical trials with medicines in Brazil "by" RDC nº 09/2015 "
p.000019: • Changed the name of the petition subject to: Global Transfer of Responsibility on DDCM (page 15).
p.000019: • Since the first edition of the Submission Manual had been finalized before the publication of the new standard,
p.000019: there was also the definition of the number of the new DRC. This was corrected in this first review.
p.000019: • Changing the name of the petition subject.
p.000019: 2nd Edition
p.000019: • Changed the name of the petition subject to: Global Transfer of Responsibility on Test Protocol
p.000019: Clinical (page 15).
p.000019: • Changing the name of the petition subject.
p.000019: 2nd Edition
p.000019: 3rd Edition
p.000019: 3rd Edition
p.000019: • Removed section "Transitional Provisions"
p.000019: • Inclusion of the following sentence in the 4th paragraph in item 6.1: “Inform, even, if the mechanism of action is innovative.”
p.000019: • Inclusion of the following sentence in the 5th paragraph in item 6.1: “A
...
Social / education
Searching for indicator educational:
(return to top)
p.000005: 5
p.000005: 4. OBJECTIVE
p.000005: 5
p.000005: 5. SUBMISSION OF DDCM AND SPECIFIC DOSSIERS FOR EACH CLINICAL TRIAL 6
p.000005: 5.1 DDCM SUBMISSION
p.000006: 6
p.000006: 5.2 SUBMISSION OF SPECIFIC DOSSIERS FOR EACH CLINICAL TRIAL 8
p.000006: 6. DDCM DOCUMENTS
p.000010: 10
p.000010: 6.1 MEDICINE DEVELOPMENT PLAN 10
p.000010: 6.2 RESEARCHER BROCHURE
p.000011: 11
p.000011: 6.2 DOSAGE FOR EXPERIMENTAL MEDICINE 12
p.000011: 7. ISSUE OF THE SPECIAL COMMUNICATE (EC) AND DOCUMENT FOR IMPORTING PRODUCT (S) UNDER INVESTIGATION OF THE DOSSIER OF
p.000011: CLINICAL MEDICINE DEVELOPMENT (DDCM)
p.000014: 14
p.000014: 8. SECONDARY PETITIONS
p.000015: 15
p.000015: 9. GLOSSARY
p.000016: 16
p.000016: 10. BIBLIOGRAPHIC REFERENCES
p.000019: 19
p.000019: 11. HISTORY OF CHANGES
p.000020: 20
p.000020: ANNEX I: Model of development plan
p.000022: 22
p.000004: 4
p.000004: MANUAL FOR SUBMISSION OF CLINICAL DEVELOPMENT DOSSIER
p.000004: MEDICINE (DDCM) AND SPECIFIC DOSAGE FOR CLINICAL TESTING
p.000004: 1. SIGLARY
p.000004: ATCC - Anatomical Therapeutic Chemical Code BI - Researcher's Brochure
p.000004: CE - Special Announcement
p.000004: DDCM - IFA Medicines Development Dossier - Active Pharmaceutical Ingredient
p.000004: ORPC - Representative Organization of Clinical Research RDC - Resolution of the Collegiate Board
p.000004: 2. INTRODUCTION
p.000004: The publication of the regulation on Clinical Trials with medicines in Brazil starts to evaluate Health Plans
p.000004: Development and not just isolated protocols. This manual is intended to provide
p.000004: guidelines for the sponsor, researcher-sponsor or ORPC to submit Development Dossiers
p.000004: Medicines Clinician (DDCM) and Specific Clinical Trial Dossiers in an appropriate manner.
p.000004: This is a non-binding regulatory measure adopted as a complement to legislation
p.000004: health, with the educational purpose of providing guidance on routines and procedures for compliance with
p.000004: legislation, not intended to expand or restrict established technical or administrative requirements.
p.000004: 3. LEGAL BASIS
p.000004: Anvisa Resolution - RDC nº 9, of February 20, 2015, which provides for the regulation for the
p.000004: conducting clinical trials with medicines in Brazil.
p.000004: 4. OBJECTIVE
p.000004: Without prejudice to the existing provisions in the legal provisions, this manual aims to guide and
p.000004: explain in a complementary way the submissions of Clinical Drug Development Dossiers (DDCM) and
p.000004: Specific Clinical Trial Dossiers, as described in chapter III of RDC No. 09/2015.
p.000004: We recommend that the format be standardized in terms of order and content to facilitate evaluation.
p.000005: 5
p.000005: MANUAL FOR SUBMISSION OF CLINICAL DEVELOPMENT DOSSIER
p.000005: MEDICINE (DDCM) AND SPECIFIC DOSAGE FOR CLINICAL TESTING
p.000005: 5. SUBMISSION OF DDCM AND SPECIFIC DOSSIERS FOR EACH CLINICAL TRIAL
p.000005: 5.1 DDCM SUBMISSION
p.000005: According to RDC No. 09/2015, the Clinical Drug Development Dossier (DDCM) is the
p.000005: compiled from documents to be submitted to Anvisa in order to evaluate the steps inherent to the development
p.000005: of an experimental drug in order to obtain information to support the registration or
p.000005: post-registration changes to that product.
p.000005: For the electronic petition of a DDCM at Anvisa, the regulated sector must inform one of the following
p.000005: primary petition matters:
p.000005: • 10750 - CLINICAL TRIALS - Consent in Process of the Clinical Development Dossier
p.000005: Medicines (DDCM) - Synthetics
...
Social / gender
Searching for indicator gender:
(return to top)
p.000024: Protocol code: Yes () No ()
p.000024: Global Start Forecast: Brazil Start Forecast: End Forecast:
p.000025: 25
p.000025: MANUAL FOR SUBMISSION OF CLINICAL DEVELOPMENT DOSSIER
p.000025: MEDICINE (DDCM) AND SPECIFIC DOSAGE FOR CLINICAL TESTING
p.000025: Fill:
p.000025: • Planned clinical trial: inform the protocol code
p.000025: • Participation of centers in Brazil: answer whether or not the participation of Brazil is foreseen in this
p.000025: clinical trial
p.000025: • Estimated number of participants: inform the number of participants expected in the study
p.000025: • Status: inform the expected date for the study to start in Brazil and in the world (if applicable) and the
p.000025: end forecast
p.000025: • Phase: inform if it is phase 1, 2, 3, etc.
p.000025: • Design: the title of the study can be informed
p.000025: • Objective: include at least the primary and secondary objectives
p.000025: • Outcome: include at least the outcomes for primary and secondary objectives
p.000025: • Comparator: inform the name of the active comparator or indicate whether it is placebo (or placebo + basic therapy) and justify
p.000025: the rationale for choosing the comparator. In the case of open studies, justify the rationale.
p.000025: • Posology of the experimental drug: inform the dose and treatment schedule
p.000025: • Posology of comparators: inform the dose and treatment schedule
p.000025: • Pharmaceutical form of the experimental drug: inform the pharmaceutical form used in this clinical trial
p.000025: • Population: inform the profile of the population (age group, gender, disease, etc.)
p.000025: • Hypothesis: inform if there is a hypothesis for the clinical trial. If yes, inform the hypothesis to be tested
p.000025: • Number of participants: inform the number of participants expected or recruited in the study
p.000025: • Statistical planning: inform at least the determination of the sample size, description of the analysis of
p.000025: effectiveness and safety.
p.000025: 9) Timeline with all clinical trials of drug development.
p.000025: Example:
p.000026: 26
p.000026: MANUAL FOR SUBMISSION OF CLINICAL DEVELOPMENT DOSSIER
p.000026: MEDICINE (DDCM) AND SPECIFIC DOSAGE FOR CLINICAL TESTING
p.000026: GENERAL OBSERVATIONS:
p.000026: ✓ The plan should be written preferably in Portuguese.
p.000026: ✓ For each new plan update, change the document version, highlight the changes made and
p.000026: send a change tracking history.
p.000026: ✓ There is no need to include the results of clinical trials in this document. The results should be
p.000026: presented in the Investigator's Brochure.
p.000026: ✓ The development plan is the first technical document to be analyzed, as it provides an overview
p.000026: of the DDCM. In this way, the more complete and clear the document is, the faster the DDCM analysis will be
p.000026: as a whole. Other documents can be referenced in this document, however, the brief description of each
p.000026: item facilitates the analysis, as it allows to quickly verify the clinical development of the drug.
p.000026: ✓ It is clarified that Anvisa understands that the Development Plan is a dynamic document, which can be changed
p.000026: throughout clinical development. However, even so, such information is fundamental for a first
...
General/Other / participants in a control group
Searching for indicator placebo:
(return to top)
p.000016: MEDICINE (DDCM) AND SPECIFIC DOSAGE FOR CLINICAL TESTING
p.000016: IX - Active Pharmaceutical Ingredient (IFA) - any substance introduced in the formulation of a pharmaceutical form that,
p.000016: when administered to a patient, it acts as an active ingredient. Such substances can exert activity
p.000016: pharmacological or other direct effect in the diagnosis, cure, treatment or prevention of a disease,
p.000016: affect the structure and functioning of the human organism;
p.000016: X - Investigator - person responsible for conducting a clinical trial at the site where the trial is conducted. If
p.000016: the study is conducted by a group of people, the researcher is the leader of the group and will be called
p.000016: principal investigator;
p.000016: XI - Investigator-Sponsor - individual responsible for conducting and coordinating
p.000016: clinical trials, alone or in a group, carried out under its immediate direction independently,
p.000016: developed with financial and material resources of the researcher, from national or international
p.000016: international research, private and non-profit entities;
p.000016: XII - Experimental medicine - pharmaceutical product under test, object of DDCM, to be used in the clinical trial,
p.000016: for the purpose of obtaining information for your registration or post-registration;
p.000016: XIII - Representative Organization for Clinical Research (ORPC) - every company regularly installed
p.000016: in national territory hired by the sponsor or by the researcher-sponsor, who assumes partial
p.000016: or totally, with Anvisa, the sponsor's duties;
p.000016: XIV - Sponsor - person, company, institution or organization responsible for initiating, managing,
p.000016: control and / or finance a clinical study;
p.000016: XV - Placebo - formulation without pharmacological effect, administered to the participant of the clinical trial for the purpose of
p.000016: masking or comparator;
p.000016: XVI - Product under investigation - experimental drug, placebo, active comparator or any other product
p.000016: to be used in the clinical trial;
p.000016: XVII - Clinical Trial Protocol - document that describes the objectives, design, methodology,
p.000016: statistical considerations and trial organization. It also provides the context and rationale for the essay
p.000016: clinical;
p.000016: XVIII - Annual Monitoring Report - annual document containing specific information
p.000016: on the conduct of a specific clinical trial in centers in Brazil, according to the clinical protocol and the BPC;
p.000016: XIX - Safety update report for experimental drug development - report
p.000016: harmonized periodical containing safety information and development of an experimental drug;
p.000017: 17
p.000017: MANUAL FOR SUBMISSION OF CLINICAL DEVELOPMENT DOSSIER
p.000017: MEDICINE (DDCM) AND SPECIFIC DOSAGE FOR CLINICAL TESTING
p.000017: XX - Active substance - is the substance with pharmacological effect for the intended therapeutic activity,
p.000017: used in the production of a given biological product.
p.000018: 18
p.000018: MANUAL FOR SUBMISSION OF CLINICAL DEVELOPMENT DOSSIER
p.000018: MEDICINE (DDCM) AND SPECIFIC DOSAGE FOR CLINICAL TESTING
p.000018: 10. BIBLIOGRAPHIC REFERENCES
p.000018: 1. BRAZIL. ANVISA. National Health Surveillance Agency. RDC Resolution No. 09, of February 20, 2015, published
p.000018: in the D.O.U. March 3, 2015. Deals with the regulation for conducting clinical trials with drugs in the
p.000018: Brazil. Official Diary of the Union; Executive Branch, of March 3, 2015.
p.000018: 2. GUIDELINE FOR GOOD CLINICAL PRACTICE. ICH E6 (R1). Available in:
...
p.000024: Pharmaceutical form of the experimental drug Population
p.000024: Hypothesis
p.000024: Statistical planning
p.000024: Global Start Forecast: Brazil Start Forecast: End Forecast:
p.000024: 8.2.2.3 Clinical Trial C
p.000024: Planned clinical trial Participation of Centers in Brazil
p.000024: Estimated number of participants
p.000024: Status
p.000024: Design Phase Objectives Outcomes
p.000024: Comparators
p.000024: Posology of the experimental drug
p.000024: Comparator dosage
p.000024: Pharmaceutical form of the experimental drug Population
p.000024: Hypothesis
p.000024: Statistical planning
p.000024: Protocol code: Yes () No ()
p.000024: Global Start Forecast: Brazil Start Forecast: End Forecast:
p.000025: 25
p.000025: MANUAL FOR SUBMISSION OF CLINICAL DEVELOPMENT DOSSIER
p.000025: MEDICINE (DDCM) AND SPECIFIC DOSAGE FOR CLINICAL TESTING
p.000025: Fill:
p.000025: • Planned clinical trial: inform the protocol code
p.000025: • Participation of centers in Brazil: answer whether or not the participation of Brazil is foreseen in this
p.000025: clinical trial
p.000025: • Estimated number of participants: inform the number of participants expected in the study
p.000025: • Status: inform the expected date for the study to start in Brazil and in the world (if applicable) and the
p.000025: end forecast
p.000025: • Phase: inform if it is phase 1, 2, 3, etc.
p.000025: • Design: the title of the study can be informed
p.000025: • Objective: include at least the primary and secondary objectives
p.000025: • Outcome: include at least the outcomes for primary and secondary objectives
p.000025: • Comparator: inform the name of the active comparator or indicate whether it is placebo (or placebo + basic therapy) and justify
p.000025: the rationale for choosing the comparator. In the case of open studies, justify the rationale.
p.000025: • Posology of the experimental drug: inform the dose and treatment schedule
p.000025: • Posology of comparators: inform the dose and treatment schedule
p.000025: • Pharmaceutical form of the experimental drug: inform the pharmaceutical form used in this clinical trial
p.000025: • Population: inform the profile of the population (age group, gender, disease, etc.)
p.000025: • Hypothesis: inform if there is a hypothesis for the clinical trial. If yes, inform the hypothesis to be tested
p.000025: • Number of participants: inform the number of participants expected or recruited in the study
p.000025: • Statistical planning: inform at least the determination of the sample size, description of the analysis of
p.000025: effectiveness and safety.
p.000025: 9) Timeline with all clinical trials of drug development.
p.000025: Example:
p.000026: 26
p.000026: MANUAL FOR SUBMISSION OF CLINICAL DEVELOPMENT DOSSIER
p.000026: MEDICINE (DDCM) AND SPECIFIC DOSAGE FOR CLINICAL TESTING
p.000026: GENERAL OBSERVATIONS:
p.000026: ✓ The plan should be written preferably in Portuguese.
p.000026: ✓ For each new plan update, change the document version, highlight the changes made and
p.000026: send a change tracking history.
p.000026: ✓ There is no need to include the results of clinical trials in this document. The results should be
p.000026: presented in the Investigator's Brochure.
p.000026: ✓ The development plan is the first technical document to be analyzed, as it provides an overview
...
Orphaned Trigger Words
p.000006: • 10483 - CLINICAL TRIALS - Consent in ORPC’s Clinical Research Process - Synthetic Drugs
p.000006: • 10478 - CLINICAL TRIALS - Consent to ORPC’s Clinical Research Process - Biological Products
p.000006: • 10477 - CLINICAL TRIALS - Consent in ORPC’s Clinical Research Process - Phytotherapics
p.000006: • 102 - CLINICAL TRIALS - Clinical Research Process Consent - Medicines
p.000006: • 1650 - CLINICAL TRIALS - Consent to the ORPC's Clinical Research Process - Medicines
p.000006: • 550- CLINICAL TRIALS - Notification in Clinical Research - Phase IV / Observational
p.000006: linked to DDCM
p.000006: The documents of a DDCM must be filed manually, at Anvisa, according to a specific check-list for
p.000006: the matter in question, except the Dossier (s)
p.000007: 7
p.000007: MANUAL FOR SUBMISSION OF CLINICAL DEVELOPMENT DOSSIER
p.000007: MEDICINE (DDCM) AND SPECIFIC DOSAGE FOR CLINICAL TESTING
p.000007: Specific (s) for each Clinical Trial that will be a new process, petitioned and filed
p.000007: electronics.
p.000007: 5.2 SUBMISSION OF SPECIFIC DOSSIERS FOR EACH CLINICAL TRIAL
p.000007: Specific Dossiers for each Clinical Trial must be submitted as primary petitions and, therefore, will have
p.000007: process number, with specific subjects for each clinical trial that is to be carried out in Brazil and that still
p.000007: have not been submitted to Anvisa.
p.000007: Specific Dossiers for Clinical Trials can be submitted to Anvisa as one of the following subjects:
p.000007: • 10482 - CLINICAL TRIALS - Clinical Research Process Consent - Synthetic Drugs
p.000007: • 10479 - CLINICAL TRIALS - Consent to Clinical Research Process - Biological Products
p.000007: • 10476 - CLINICAL TRIALS - Consent in Clinical Research Process - Phytotherapics
p.000007: • 10773 - CLINICAL TRIALS - Consent in Clinical Research Process - Radiopharmaceuticals
p.000007: • 10483 - CLINICAL TRIALS - Consent in ORPC’s Clinical Research Process - Synthetic Drugs
p.000007: • 10478 - CLINICAL TRIALS - Consent to ORPC’s Clinical Research Process - Biological Products
p.000007: • 10477 - CLINICAL TRIALS - Consent in ORPC’s Clinical Research Process - Phytotherapics
p.000007: • 10774 - CLINICAL TRIALS - Consent in ORPC’s Clinical Research Process - Radiopharmaceuticals
p.000007: • 550- CLINICAL TRIALS - Notification in Clinical Research - Phase IV / Observational
p.000007: linked to DDCM
p.000007: Specific Dossiers for each Clinical Trial can be requested by institutions with CNPJ
p.000007: different from that informed in the DDCM. To petition the matters above, it must be informed
p.000007: the DDCM case number to which the Clinical Research Process Consent petition must be
p.000007: linked, as the system does not allow these matters to be petitioned without belonging to any DDCM.
p.000008: 8
p.000008: MANUAL FOR SUBMISSION OF CLINICAL DEVELOPMENT DOSSIER
p.000008: MEDICINE (DDCM) AND SPECIFIC DOSAGE FOR CLINICAL TESTING
p.000008: The specific check-list for each subject mentioned above can be consulted on Anvisa's website and
p.000008: these strictly follow the description of the items required by the current regulation.
p.000008: Petitioning and filing must be done electronically. For each item contained in the checklist
p.000008: of these requests, it will be necessary for the applicant to attach at least one PDF file, which allows textual search.
p.000008: It will be possible to attach up to 5 files in the size of 750 Kb. For clarity, we recommend that the annex referring to
p.000008: the protocol is identified as "Protocol".
p.000008: For the application process to continue, each attached file must be viewed. After
p.000008: Upon completion of the petition, a transaction number is generated. In cases of fee collection, it is not
p.000008: It is not possible to make any changes to the dossier submitted after the payment of the fee has been made. Any
p.000008: subsequent changes can be made using a specific subject code.
p.000008: It should be noted that only dossiers for clinical trials to be carried out in Brazil should be requested. Only
p.000008: dossiers that already have a clinical and non-clinical basis must be filed to be initiated,
p.000008: therefore, the CE issued for DDCM, will only contain clinical trials that Anvisa considers subject to
p.000008: initiated. If a Development Plan is presented in a complete form containing tests
p.000008: phase 1, 2 and 3 clinical trials, but studies are still being carried out in the early stages, which
p.000008: able to subsidize later phase clinical trials, the phase 3 clinical trial, for example
...
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| age | Age |
| drug | Drug Usage |
| educational | education |
| gender | gender |
| language | Linguistic Proficiency |
| placebo | participants in a control group |
| substance | Drug Usage |
| union | Trade Union Membership |
Indicator Peers (Indicators in Same Vulnerability)
| Indicator | Peers |
|---|
| drug | ['substance'] |
| substance | ['drug'] |
Trigger Words
consent
risk
Applicable Type / Vulnerability / Indicator Overlay for this Input