Why proposed African medicines regulatory agency is a big deal

Dr Niyikiza speaks at a past event in Kigali. File.

A cabinet meeting on Monday approved the ratification of the treaty establishing the African Medicines regulatory Agency, a continental body whose aim is to regulate medicines and medical products in Africa.

The move paves way for the Rwandan parliament to ratify the treaty.


The treaty that establishes the African Medicines Agency (AMA) was unanimously adopted last year by the African ministers of health.


While it is not yet clear how long it would take before the organisation begins operations, the AU, World Health Organisation (WHO) and the New Partnership for Africa’s Development (NEPAD) had jointly given themselves four years (2015-2018) of preparation.


What is clear at the moment is that health experts and public officials are betting on the body to bridge the gaps in the regulation of medical products like medicines, vaccines, pharmaceutical ingredients, medical devices, and diagnostics which are imported in Africa.

Doctor Clet Niyikiza, a Rwandan Medical Researcher based in the United States told The New Times that the agency would be a catalyst for African nations to fight counterfeit and substandard medicines.

“By harmonising, reviewing and approving medicines entering Africa, this Agency brings us a critical step closer to ensuring that falsified or substandard medicines are kept away from harming lives on the continent,” he said.

He described Rwanda’s step to ratify the treaty as an important leadership step as well as a commitment by the country to the well-being of Rwandans. 

Niyikiza who has advised the AU in the process of the establishment of this organisation is optimistic that it would also regulate how legitimate investments in the African pharmaceutical space are directed.

The situation

The WHO reports that 1 out of every 10 medicines in Africa is substandard or falsified. 

These poor-quality products result in significant deaths annually. 

A review of available several reports seem to suggest that lack of regulation and quality assurance has allowed a flourishing market of substandard, spurious, falsely-labelled, falsified and counterfeit (SSFFC) medical products to emerge in parts of the developing world.

According to WHO, SSFFC medical products are by their nature difficult to detect.

They are often designed to appear identical to the genuine product and may not cause an obvious adverse reaction, however they will fail to treat the disease or condition for which they were intended.

There is generally scarce information on the extent of quality and safety of medical products in African countries due to inadequate regulatory systems

Charles Karangwa who heads the Rwanda Food and Drugs Authority indicated that the agency is the right solution, and national agencies like his have already started to confront the problems to which the new organ intends to solve.

“The establishment of the new agency would be a great mechanism to counter falsified and counterfeit medicines in Africa and that would consequently improve public health. We have already started to deal with such problems through providing know-how to our people,” he noted.

The official highlighted that they have started collaborating with the US FDA to send local laboratory technicians to acquire scientific and technical know-how.

He also said that the Rwanda FDA has begun the process of putting in place a national registry of all available medicines and medical products that are available of the market.

This would mean that in the near future all medical products will undergo rigorous investigation before they are commercialised.


The African Heads of State and Government as well as the WHO regional committee for Africa made a decision to establish the Agency in response to the enormous health challenges including lack of access to affordable, quality essential medicines.

Currently, Africa has a high disease burden and high mortality from preventable and curable diseases, which affects populations at various levels.

This is attributed partly due to inadequate health systems, scarce financial and human resources and unavailable and unaffordable medicines that are good quality, safe and efficacious.

Lack of access to quality essential medicines and health products is just one of the contributing factors to the enormous health challenges that Africa faces.

Experts suggest the regulation of pharmaceuticals is an essential part of improving health care while supporting social and economic productivity of the African population.

The organisation is intended to be an organ with the goal of increasing availability of affordable, quality, safe and efficacious medicines and other health products on the continent.


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