Cameroon: African Medicines Agency - Better Regulation Is Imperative

The organ will effectively address the issue of the availability and quality of medical products in Africa as well its production and distribution.

The cry for the establishment of the African Medicines Agency (AMA) has come to an end.

The Treaty for the establishment of the AMA will go operational from November 5, as Cameroon has become the 15th country to deposit the instrument of ratification into AMA. The African Union Special Envoy for the AMA, Michel Sidibé is amongst those who have lauded the importance of AMA, at a time when the world is facing a major health crisis.

Information states that the African Medicines Agency is a Specialized Agency of the African Union with its own rules, membership and resources to enhance the capacity of State Parties and Regional Economic Communities (RECs), to regulate medical products in order to improve access to quality, safe and efficacious medical products on the continent. The Agency shall also build on the strengthened capacity of medical products regulation in Africa and the harmonization of regulatory systems, within the context of the African Medicines Regulatory Harmonization (AMRH) Initiative. When it becomes operational, AMA is expected to link up existing national regulatory systems with the continent-wide approval mechanism, to speed up review and approval processes, improving access to essential medicines.

Market Surveillance, Supply Security

According to its functions, AMA would assist in the "identification, prevention, detection and response strategies" in delivering quality medication across Africa. Experts have revealed that this is vital especially with the Covid-19 pandemic and the need to fill gaps and inconsistencies in the current patchwork of regulations that exist among the continents five regional regulatory authorities and dozens of national authorities. With the proliferation of false information surrounding the pandemic, experts explained that the lack of national regulatory and technical capacity has been one of the weak points around (the pandemic) causing people to go outside traditional marketplaces for medications. This, in turn, places patients in grave danger-because they secure medications through channels where the products are not vetted and tested through AMA, processes like "market surveillance" and "supply chain security" could be implemented to better protect patients.

African Medicine for Africa, the World

Another important aspect of the AMA's work will be to improve the supervision and regulation of African traditional medicine, said Isaac Nii Ofoli Anang, chairperson of the African Regional Office of the International Pharmaceutical Students' Federation (IPSF). This is particular in a time when there is need to improve access, safety and transfer of traditional medicines to help augment their production and distribution across the continent." It has been revealed that AMA serves two key roles, that of education and that of science. With respect to education, as in the case of African traditional medicine, the agency would serve to streamline education of a medicinal regulation framework. Speaking about science, it is said AMA would serve to harmonize the "scientific processes to improve on local drug production and distribution pharmacies and pharmacies."

Civil Society and Free Trade Concerns

The establishment of the African Continental Free Trade Area (AfCFTA), which will make Africa the largest integrated trading area in the world, allowing access without tariffs to a market of over 1.2 billion potential consumers and by extension creating an African Economic Community by 2028, will have significant importance to public health and safety Pharmaceuticals are amongst the most traded products in Africa, FTA could actually open the doors wider to the proliferation of poor quality and poorly regulated pharmaceuticals being trading across several borders with little or no control to the potential detriment to all Africans. AMA is here to close such loopholes.

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