NATIONAL ADMINISTRATION OF MEDICINES, FOOD AND MEDICAL TECHNOLOGY
Provision 10017-E / 2017
City of Buenos Aires, 09/18/2017
HAVING SEEN the Provisions A.N.M.A.T. No. 6677/10, 4008/17, 4009/17 and file No. 1-47-11886-17-5 of the registry of this National Administration of Medicines,
Food and Medical Technology, and
CONSIDERING:
That by Provision A.N.M.A.T. Nº 6677/10 the Regimen of Good Clinical Practices for Clinical Pharmacology Studies was approved, having as a substantive objective
guarantee and ensure maximum compliance with the established rules, both national and international, regarding ethical and legal norms and values.
That by Provisions A.N.M.A.T. No. 4008/17 and 4009/17 new procedural aspects were established for the presentation, evaluation and authorization of studies of
clinical pharmacology.
What is the purpose of this A.N.M.A.T. contribute to the strengthening and convergence of operational criteria regarding the evaluation of the ethical aspects involved in
proposals for carrying out the aforementioned studies.
That the active participation of all health jurisdictions in that same purpose is timely and necessary, strengthening the evaluating and auditing bodies
local and helping to unify the prevailing criteria in the country.
That also constitutes an additional guarantee for the subjects participating in clinical pharmacology studies than the jurisdictional authorities, through the committees
of ethics, are involved in the evaluation and authorization process of the studies that are carried out in their respective jurisdictions.
That the National Institute of Medicines, the Directorate for Evaluation and Registration of Medicines of INAME and the General Directorate of Legal Affairs, have taken the
intervention of its competition.
That it acts by virtue of the powers conferred by Decree No. 1490/92 and Decree No. 101 dated December 16, 2015.
Thus,
THE NATIONAL ADMINISTRATOR OF THE NATIONAL ADMINISTRATION OF MEDICINES, FOOD AND MEDICAL TECHNOLOGY,
HAS:
ARTICLE 1.- The signing of cooperation agreements between this National Administration and the health authorities of each provincial jurisdiction and the City is promoted.
Autonomous of Buenos Aires (CABA), in order that they assume the commitment to evaluate and monitor the ethical and methodological aspects of the studies of
clinical pharmacology that are carried out in their respective jurisdictions, as well as the evaluation of the level of complexity of the research center and the
background and suitability of the principal investigator.
ARTICLE 2º.- The cooperation agreement will contemplate that for the clinical pharmacology studies to be initiated in each jurisdiction, the highest health authority, or whoever
reliably designate, within the term established in article 5 of the A.N.M.A.T. No. 4008/17, which replaces point 2.2 of the Annex to the Provision
A.N.M.A.T. No. 6677/10, will provide the following information:
1) In relation to the Research Ethics Committee (CEI) and the Informed Consent:
a) Name and address of the CEI involved.
b) CEI means of contact (email, telephone, and / or others)
c) Version of the informed consent approved by the CEI.
d) Detailed opinion of the result of the evaluation carried out by the acting CEI countersigned by the Ministry of Health of the jurisdiction, or the authority designated by it.
2) In relation to the Research Center:
a) Name and address of the research center
b) Means of contact of the research center (email, telephone, and / or others)
c) Definition of the level of care complexity of the center, and its correspondence with the requirement of the proposed clinical study.
3) Regarding the main researcher:
a) Last name and first name of the principal investigator.
b) Curriculum vitae of the main researcher (detailing means of contact).
c) Correspondence of their history and suitability with the requirement of the proposed clinical study.
ARTICLE 3º.- The A.N.M.A.T. Federal will be in charge of managing and facilitating all the aspects inherent in specifying the signing of the agreements.
ARTICLE 4º.- Register. Give it to the National Directorate of the Official Registry for publication. Contact the Undersecretariat for Policies, Regulation and Oversight of the
Ministry of Health of the Nation, to all the ministries of Health of the provincial jurisdictions and of the Autonomous City of Buenos Aires (CABA), to the Industrial Chamber
from Argentine Pharmaceutical Laboratories (CILFA), to the Argentine Chamber of Medicinal Specialties (CAEMe), to the Business Chamber of Pharmaceutical Laboratories
(COOPERALA), to the Argentine Chamber of Clinical Research Organizations (CAOIC), to the Argentine Chamber of Producers of Generic and Use Medicines
Hospital (CAPGEN), and the Argentine Chamber of Over-the-Counter Medicines (CAPEMVeL). Contact the National Institute of Medicines, the Directorate of
Computing and the Planning and Institutional Relations Directorate. Fulfilled, file. - Carlos Alberto Chiale.
and. 09/21/2017 N ° 70307/17 v. 09/21/2017