Guinea Profile Updated
The Guinea profile in ClinRegs has been reviewed and updated with the following information:
- Legislation defining the National Directorate of Pharmacy and Medicine (Direction Nationale de la Pharmacie et du Médicament (DNPM))’s drug registration, authorization, and importation oversight responsibilities (See Regulatory Authority)
- Guidance providing DNPM operational procedures (See the Regulatory Authority topic)
- Legislation establishing Guinea’s personal data protection requirements (See Definition of Sponsor and Quality, Data & Records Management)
- Updated National Ethics Committee for Health Research (Comité National d'Ethique pour la Recherche en Santé (CNERS)) standard operating procedures for reviewing a health research protocol (See the Ethics Committee topic, Clinical Trial Lifecycle topic, and Documentation Requirements)
Sources Added During this Update:
(Legislation) Law L/2016/037/AN Relating to Cybersecurity and the Protection of Personal Data in the Republic of Guinea (PDPLaw - French) (July 28, 2016)
The National Assembly
(Legislation) Ordinary Law No. L/2018/024/AN Relating to Medicines, Health Products and the Practice of the Pharmacist Profession (PharmLaw - French) (June 20, 2018)
The National Assembly
(Guidance) Manual of Administrative, Financial, Accounting and Operational Procedures: Volume 6 Operational Procedures (ManOpProcs - French) (Final Version) (August 2018)
Ministry of Health and Public Hygiene
(Article) Guinea Updates Its Pharmaceutical Regulatory Law (GIN-22) (French) (Date Unavailable)
Promoting the Quality of Medicines (PQM), United States Agency for International Development (USAID)
(International Guidance) Declaration of Helsinki (GIN-23) (October 19, 2013)
World Medical Association
(International Guidance) International Ethical Guidelines for Health-Related Research Involving Humans (GIN-24) (2016)
Council for International Organizations of Medical Sciences (CIOMS)
(International Guidance) Operational Guidelines for Ethics Committees that Review Biomedical Research (GIN-25) (2000)
World Health Organization
(Webpage) Guinea - Contact Information (GIN-27 - French) (Current as of August 24, 2022)
Health Research Web
(Webpage) Ministry of Health and Public Hygiene - Contact Information (GIN-26 - French) (Current as of August 24, 2022)
Go Africa Online
(Webpage) National Ethics Committee for Research in Health (CNERS) - Submission (GIN-21 - French) (Current as of August 24, 2022)
National Ethics Committee for Research in Health
Sources Revised During this Update:
(Document) Standardized Operating Procedure (SOP) for Reviewing a Health Research Protocol (GIN-5 - French) (GoogleTranslate-GIN-5) (Version 6) (February 2021)
National Ethics Committee for Research in Health (CNERS)