To foster scientific excellence in the evaluation and supervision of medicines, for the benefit of public health, the Ministry in charge of health of the Republic of Congo has initiated a plan to strengthen the regulatory capacity of its Department of Pharmacy and Medicines implemented by its director, Dr Boniface OKOUYA. This process is based on a strong commitment to pharmaceutical reform for which the law will be promulgated shortly. It is in this momentum that the Directorate of Pharmacy and Medicines in partnership with the World Health Organization (WHO) and the Africlinique project, a regulatory capacity building project in Central Africa (funded by the European Union through EDCTP), will carry out a self-assessment of its pharmaceutical regulatory system using the Global Benchmarking Tool (GBT) developed by the WHO, which also focuses on clinical trials oversight.
The workshop for the preparation and validation of the draft decree establishing a national pharmacovigilance system in the Republic of Congo, supervised by the Director of Pharmacy and Medicines, Dr Boniface Okouya (Member of Africlinique) was held from 23 to 24 October 2020 in Brazzaville, Republic of Congo. This workshop was also devoted to the development of the national pharmacovigilance guide and the notification forms for adverse reactions to medical products which are part of the tools of the national pharmacovigilance system.
Dr Boniface Okouya included this workshop within the framework of the pharmaceutical reform process. Indeed, “As part of its sovereign role of guaranteeing public health in the Republic of Congo, the Congolese government, under the leadership of the Minister of Health, Population, Promotion of Women and Integration of women in development, Jacqueline Lydia Mikolo, is firmly committed to the process of pharmaceutical reform. The establishment of a national pharmacovigilance system is one of the key results expected from this reform” said Dr Boniface Okouya, in his capacity as the National Pharmaceutical Regulatory Authority (ANRP).
A strong pharmacovigilance in Central Africa is also an objective of the EDCTP-funded project Africlinique.
The Africlinique Project Manager, Jolivet Mayela, Project Manager also at the Congolese Foundation for Medical Research (FCRM) headed by Prof. Francine Ntoumi (also Africlinique Coordinator), believes that the establishment of a national pharmacovigilance system should crown all the efforts of the last decade. “Because, in terms of drug safety, the ministry in charge of health has the mandate, through the Department of Pharmacy and Medicines, to guarantee the rational use of medicines and health products to the populations. Indeed, badly used or stored drugs can become more harmful than a poison” he said. Jolivet Mayela also welcomed the fact that the draft decree also takes into account the need to better regulate the use of traditional health products, whether improved or not.
Proud to have had the Africlinique Coordinator Professor Francine Ntoumi (Founder, Chair and Executive Director of the Congolese Foundation for Medical Research / Coordinator for CANTAM and PANDORA-id-NET) as speaker in the webinar “The EDCTP Knowledge Hub: Providing tools and guidance for conducting clinical research”.
The Africlinique network organised together with CANTAM (the EDCTP-funded Central Africa Network on Tuberculosis, HIV/AIDS and Malaria, coordinated by Prof. Francine Ntoumi of the Fondation Congolaise pour la Recherche Médicale – FCRM, Brazzaville, Republic of the Congo), a webinar on the regulatory conditions for research (preparation) during epidemics. The webinar was succesfully completed on 5th and 6th August 2020 with a large participation of a variety of audience and stakeholders.