Project: Strengthening the regulatory framework to upgrade ethical review of clinical research and drugs safety monitoring in Cameroon

Acronym	BREEDSAFCA (Reference Number: CSA2017ERC-1911)
Duration	01/11/2018 - 30/04/2021
Project Topic	In Cameroon, ethics review has made remarkable progress since 2009 thanks to a stronger political will coupled with support from national and international partners. This progress however remains limited because existing regulations are not fully elaborated on ethical/administrative evaluation of clinical research and the protection of participants involved. Furthermore, prerequisites indispensable for good performance of existing ethics committees and regulatory bodies are not guaranteed. Cameroon’s population is constantly exposed to the huge amount of drugs. The recommended system to detect, report, investigate and prevent known and unknown Adverse Events Following Exposure to Drugs (AEFED) exists, but performs poorly only in one out of eight health programs using drugs and is not implemented at health facilities. The present project matches the current EDCTP call, having as an aim to firstly strengthen the regulatory framework of Cameroon's ethical and administrative evaluation of clinical research and pharmacovigilance, and, secondly, to improve the coverage of national territory with RECs and research teams prepared for better protection of research participants and with pharmacovigilance units capable of ensuring the monitoring of drug safety. Two commissions will be set up for the revision of existing regulations and the proposition of new ones on ethical evaluation of clinical research and on pharmacovigilance. Performance of competent actors involved in research participants protection and on monitoring of drug safety will be evaluated and improved. Two new regions and two universities will be accompanied in the process of setting up ethics committees. Two health programs and one health region will be accompanied in the process of setting up pharmacovigilance units. This project will run under the leadership of the Division of Health Operational Research of the Cameroon Ministry of Public Health. This Division’s duty is to regulate biomedical research, establish RECs and issue administrative authorizations for research. This will be done in collaboration with the Cameroon National Ethics Committee that reviews clinical research protocols; the Directorate of Pharmacy, Laboratory and Drugs that regulates pharmacovigilance; and other national and international partners. From the implementation of this project, we expect to improve the coverage and performance of competent structures in protecting research participants and in monitoring the safety of marketed medicines and vaccines in Cameroon.
Network	EDCTP2
Call	Ethics and regulatory capacities 2017

Project partner

Number	Name	Role	Country
1	Ministry of Public Health - Cameroon	Coordinator	Cameroon
2	Meilleur Accès Aux Soins de Santé	Partner	Cameroon