79C3C34C52B45572883A05D425EB0F82
Act 851, Sections 150-166
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This file was generated: 2020-12-01 09:15:21
| 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:
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p.(None): REGULATION OF CLINICAL TRIALS IN GHANA
p.(None):
p.(None): Scope
p.(None):
p.(None): This guide covers applications for Clinical Trials as defined under Section 150-166 (Part
p.(None): 8) of the Public Health Act 2012, Act 851.
p.(None):
p.(None): This document is intended to give guidance to applicants in making applications on Clinical Trials on
p.(None): medicinal products, medical devices or procedures or herbal medicines to the Food and Drugs
p.(None): Authority as the competent Authority for their regulation.
p.(None):
p.(None): These Guidelines cover the regulatory requirements for authorization of clinical trials in Ghana and are intended
p.(None): to be applied during all clinical stages of drug development prior to and subsequent to product
p.(None): registration. These Guidelines are addressed to investigators, the pharmaceutical industry, Clinical
p.(None): Research Organizations and sponsors of clinical trials, whether for academic purposes or for generation
p.(None): of data, intended for inclusion in the regulatory submissions for medicinal products.
p.(None):
p.(None): Clinical trials shall be categorized as follows:
p.(None): 1. FDA recommended trials
p.(None): 2. Trials initiated by pharmaceutical companies or agencies
p.(None): 3. Trials initiated by academic and research institutions either locally or as part of an international multi-centre
p.(None): study
p.(None): Guidance on applications to Ghana Health Service Ethical Review Committee and or Institutional Review Board may
p.(None): be found on their respective websites.
p.(None):
p.(None): Introduction
p.(None):
p.(None): These Guidelines seek to ensure that clinical trials conducted in Ghana are designed and conducted according to sound
p.(None): scientific principles and ethical standards within the framework of good clinical practice. Compliance with
p.(None): these Guidelines provides the public with assurance that the rights, safety and wellbeing of trial
p.(None): participants are protected.
p.(None):
p.(None): Application
p.(None):
p.(None): Before an application can be submitted to the Authority, the Sponsor must submit proof of registration of the trial
p.(None): with a Clinical Trial Registry. The Authority recommends the Pan African Clinical Trials Registry (PACTR). The
p.(None): applicant may visit the website of PACTR (www.pactr.org), register as a user and follow the instructions
...
Health / patients in emergency situations
Searching for indicator emergencies:
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p.(None):
p.(None): Pre-submission meetings are also encouraged to discuss pertinent issues prior to formal submissions.
p.(None):
p.(None): Timelines
p.(None):
p.(None): Clinical Trial Application process takes maximum of 60 working days. This excludes time taking for
p.(None): applicant to respond to FDA queries. (refer to Appendix 2 of this Guideline).
p.(None):
p.(None): Additional Information
p.(None):
p.(None): For additional guidance on making an application for Clinical Trials and on Adverse Reaction reporting,
p.(None): the applicant may consult the FDA’s Clinical Trials Application (CTA) Form and the Guidelines for Adverse
p.(None): Reaction Reporting on the website www.fda@fdaghana.gov.gh.
p.(None):
p.(None): Fees for Clinical Trial Authorization
p.(None): Category Rates (US$) Rates (GH¢)
p.(None): Industry Funded (Phase I) 15,000.00
p.(None): Industry Funded (Phase II) 12,000.00
p.(None): Industry Funded (Phase III) 10,000.00
p.(None): Investigator/local phases 3 & 4 7,000.00
p.(None): Research Institution funded 5,000.00
p.(None): Academic Research Trial (Individual)* 2,000.00 Amendment to
p.(None): Clinical Trial protocol 1,000.00
p.(None):
p.(None): Links to the Guidelines
p.(None):
p.(None): • Guidelines for Authorization of Clinical Trials of Medicines, Food Supplements, Vaccines and Medical Devices in
p.(None): Ghana
p.(None): • Guidelines for Conduct of Clinical Trials in Paediatric Population
p.(None):
p.(None): • Guidelines for Conduct of Clinical Trials during Emergencies
p.(None):
p.(None): • Guidelines for Good Clinical Practice in Ghana
...
General/Other / Relationship to Authority
Searching for indicator authority:
(return to top)
p.(None): REGULATION OF CLINICAL TRIALS IN GHANA
p.(None):
p.(None): Scope
p.(None):
p.(None): This guide covers applications for Clinical Trials as defined under Section 150-166 (Part
p.(None): 8) of the Public Health Act 2012, Act 851.
p.(None):
p.(None): This document is intended to give guidance to applicants in making applications on Clinical Trials on
p.(None): medicinal products, medical devices or procedures or herbal medicines to the Food and Drugs
p.(None): Authority as the competent Authority for their regulation.
p.(None):
p.(None): These Guidelines cover the regulatory requirements for authorization of clinical trials in Ghana and are intended
p.(None): to be applied during all clinical stages of drug development prior to and subsequent to product
p.(None): registration. These Guidelines are addressed to investigators, the pharmaceutical industry, Clinical
p.(None): Research Organizations and sponsors of clinical trials, whether for academic purposes or for generation
p.(None): of data, intended for inclusion in the regulatory submissions for medicinal products.
p.(None):
p.(None): Clinical trials shall be categorized as follows:
p.(None): 1. FDA recommended trials
p.(None): 2. Trials initiated by pharmaceutical companies or agencies
p.(None): 3. Trials initiated by academic and research institutions either locally or as part of an international multi-centre
p.(None): study
p.(None): Guidance on applications to Ghana Health Service Ethical Review Committee and or Institutional Review Board may
p.(None): be found on their respective websites.
p.(None):
p.(None): Introduction
p.(None):
p.(None): These Guidelines seek to ensure that clinical trials conducted in Ghana are designed and conducted according to sound
p.(None): scientific principles and ethical standards within the framework of good clinical practice. Compliance with
p.(None): these Guidelines provides the public with assurance that the rights, safety and wellbeing of trial
p.(None): participants are protected.
p.(None):
p.(None): Application
p.(None):
p.(None): Before an application can be submitted to the Authority, the Sponsor must submit proof of registration of the trial
p.(None): with a Clinical Trial Registry. The Authority recommends the Pan African Clinical Trials Registry (PACTR). The
p.(None): applicant may visit the website of PACTR (www.pactr.org), register as a user and follow the instructions
p.(None): on how to register a Clinical Trial. Proof of this registration is to be submitted as part of the CTA during
p.(None): submission to the Authority.
p.(None): A Clinical Trial may only be conducted in Ghana if:
p.(None):
p.(None): a) The applicant receives approval from the Ethics Committee(s) responsible for the intuition(s) where the trial is to
p.(None): be conducted.
p.(None):
p.(None): FDA Clinical Trials Application Guide
p.(None):
p.(None): b) The Authority has issued a final Clinical Trial Authorization certificate
p.(None):
p.(None): c) The Principal Investigator is resident in Ghana.
p.(None):
p.(None): Applicant should note that Parallel submission to ethics committee is allowed to reduce any unnecessary delays; however
p.(None): final Clinical Trials Authorization Certificate is issued by the FDA.
p.(None):
p.(None): Pre-Submission
p.(None):
p.(None): Pre-submission meetings are also encouraged to discuss pertinent issues prior to formal submissions.
p.(None):
p.(None): Timelines
p.(None):
p.(None): Clinical Trial Application process takes maximum of 60 working days. This excludes time taking for
p.(None): applicant to respond to FDA queries. (refer to Appendix 2 of this Guideline).
p.(None):
p.(None): Additional Information
p.(None):
p.(None): For additional guidance on making an application for Clinical Trials and on Adverse Reaction reporting,
p.(None): the applicant may consult the FDA’s Clinical Trials Application (CTA) Form and the Guidelines for Adverse
p.(None): Reaction Reporting on the website www.fda@fdaghana.gov.gh.
p.(None):
p.(None): Fees for Clinical Trial Authorization
p.(None): Category Rates (US$) Rates (GH¢)
p.(None): Industry Funded (Phase I) 15,000.00
p.(None): Industry Funded (Phase II) 12,000.00
p.(None): Industry Funded (Phase III) 10,000.00
p.(None): Investigator/local phases 3 & 4 7,000.00
p.(None): Research Institution funded 5,000.00
p.(None): Academic Research Trial (Individual)* 2,000.00 Amendment to
...
Orphaned Trigger Words
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| authority | Relationship to Authority |
| drug | Drug Usage |
| emergencies | patients in emergency situations |
Indicator Peers (Indicators in Same Vulnerability)
Trigger Words
ethics
Applicable Type / Vulnerability / Indicator Overlay for this Input