Strides taken to establish a single continental Medicines Regulatory Agency in Africa


The African Medicines Agency (AMA) will be a single, fully-fledged continental medicines regulatory agency of the African Union, dedicated to assisting Member States to improve their capacities to regulate medical products and health technologies, and to continue to build on existing AMRH (African Medicines Regulatory Harmonization) initiatives. A single continental medicines regulatory agency can improve access to medicines to those most in need and disrupt the cycle of poverty on the African continent. However, in order for AMA to become a reality, all African Member States need to sign and ratify the AMA Treaty. The AMA Treaty was adopted by AU Assembly on February 11 2019.

A minimum of 15 Member States are needed to ratify the AMA Treaty in their national Parliaments for AMA to come into force. So far 17 countries have signed, out of which Burkina Faso, Mali and Rwanda have ratified. They are; Algeria, Benin, Burkina Faso, Chad, Gabon, Ghana, Guinea, Madagascar, Mali, Morocco, Niger, Rwanda, Saharawi Arab Republic, Senegal, Seychelles, Sierra Leone and Tunisia.

The AMA Treaty is open to signature by all AU Heads of State and Government and/or by Ministers of Foreign Affairs, either in person or by designation in writing to their Ambassador accredited to the African Union. Ratification processes vary by Member State, depending on whether legislative ratification or executive ratification applies.

AMA, once legally mandated by AU Member States (MS), will be an established organ of AU and will facilitate availability of quality, safe and efficacious medical products and health technologies on the continent. This will be achieved through co-ordinating national and regional regulatory systems for medical products, providing regulatory oversight of selected medical products as well as promoting co-operation, harmonisation and mutual recognition of regulatory decisions.

The Agency offers the opportunity for a continental focus for certain activities, such as the opportunity to assess special classes of medicines (e.g. advanced therapies), Active Pharmaceutical Ingredients (APIs) and products that are currently not well regulated in many African countries (IVDs and devices, traditional medical products). AMA will collaborate with Regional Economic Communities (RECs) and national medicines regulatory agencies in the identification of substandard and falsified medical products, and facilitate information sharing across countries with the goal of providing a better environment for legitimate manufacturers to flourish and improve local manufacturing of quality products.

The Agency offers an opportunity to catalyse financial and technical support from countries and undertake certain activities more efficiently, while at the same time consolidating the RECs’ initiatives. It is also expected to play a key role by working closely with the Africa-CDC and WHO on the evaluation of, and oversight for the use of medical countermeasures for public health emergencies. Continent-wide alignment of regulatory technical requirements and standards through AMA is likely to make Africa a more attractive market for the pharmaceutical sector for both research and development, as well as introduction of innovations. AMA further plays a critical role in catalysing trade in support of the African Continental Free Trade Area (AfCFTA).

“The African Medicines Agency will be a single, fully fledged continental medicines regulatory agency of the African Union, dedicated to assisting Member States to improve their capacities to regulate medical products and health technologies.” @Nepad_Agency



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