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REG-PHARMA
Project
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Project start date
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Status
Ongoing
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Project end date
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Financing amount (Euro)
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5M €
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Country and region
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Benin, Cameroon, Congo, Ivory Coast, Gabon, Equatorial Guinea, Guinea-Bissau, Central African Republic, Senegal, Chad, Togo
Financed by Agence Française de Développement, the REG-PHARMA project aims to strengthen the regulation of the pharmaceutical sector in West and Central Africa.
Access to safe, effective, quality and affordable health products poses a major challenge in Africa, in particular for West and Central African countries. This challenge is further complicated by the lack of harmonisation of pharmaceutical practices and regulation, as some countries belong to several regional economic communities.
A great many countries have undertaken to establish Universal Health Coverage (UHC) to ensure access to safe, quality and affordable essential medicines and vaccines. In addition, several Member States of the African Union (AU) have started to manufacture health products, which requires strengthening the pharmaceutical regulatory framework. This particularly concerns the approval of health products, the inspection of pharmaceutical establishments, and the supervision of the pharmaceutical market to ensure that the manufacturing and marketing of these products comply with international standards.
Building the capacities of regional authorities to establish harmonised regulations
The Regional Committee of Regulation Harmonization and Pharmaceutical Cooperation of the West African Economic and Monetary Union (WAEMU) and the Economic and Monetary Community of Central Africa (CEMAC) have made many efforts to harmonise pharmaceutical policies, in the context of the HPPN/OCEAC programme. Yet there are still major shortcomings in the regulation, in particular concerning the approval of pharmaceutical products, the inspection of pharmaceutical establishments, and market surveillance.
To address them, REG-PHARMA facilitates the development of activities to build the capacities of these authorities to implement a harmonised regulatory framework by 2027, even in health emergency situations. The member countries of these regional authorities should thereby be able to ensure access to quality and innovative therapeutic treatments through regulatory harmonisation and technical cooperation. Other factors external to the project, such as effective social protection systems, the mobilisation of industrial investment and strong inter-State technical cooperation, will also be essential to the achievement of this impact.
The national pharmaceutical regulatory agencies in Benin and Gabon aligned with international standards
Under a second component of the activities, the REG-PHARMA project is focusing on strengthening two national pharmaceutical regulatory agencies (NPRAs), the Beninese Medicines Agency (ABMed) and the National Agency for Medicines and Other Health Products of Gabon (ANMAPS).
The activities to support these agencies aim to ensure that they comply with the standards of two bodies:
- WHO, which assesses their level of maturity for all the regulatory functions using the Global Benchmarking Tool (GBT), and
- AUDA-NEPAD, the African Union (AU) agency which attributes the status of Regional Centre of Excellence (RCE) to NPRAs that are very advanced in certain regulatory functions
A Regional Centre of Excellence to strengthen HR competencies in pharmaceutical regulation
The network of French-speaking expertise has developed little over the last ten years, in contrast to the network in English-speaking African countries. In the context of the REG-PHARMA project, Expertise France aims to play a role in building a network of French-speaking expertise in Central and West Africa in the field of pharmaceutical regulation, and thereby meet the human resources needs of NPRAs in the region. To this end, the project aims to establish a Regional Centre of Excellence on a scale to meet the human resources training needs of the NPRAs.
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