Treaty for the establishment of the African Medicines Agency (AMA) enters into force

ETHIOPIA – The Treaty for the Establishment of the African Medicines Agency (AMA) has entered into force, thirty days after the deposit of the 15th instrument of ratification, on the 5th of October 2021, by the Republic of Cameroon at the African Union Commission.

The treaty which came to life on 5th November, brings the journey that began in 2009, through establishment of the African Medicines Regulatory Harmonisation Initiative (AMRH) and the involvement of many key partners to a close end.

“The African Union Commission celebrates and welcomes this great milestone that opens a new chapter for harmonization and regulation of the African pharmaceutical landscape, across the continent and the efforts to improve weak regulatory systems,” said H.E. Amira Elfadil Mohammed, Commissioner for Health, Humanitarian Affairs and Social Development, who has been leading advocacy efforts towards the establishment of AMA.

The African Union Assembly adopted a treaty to establish the AMA to enhance regulatory oversight across the continent and meet the challenges of access to quality, safe, and efficacious medicines in the continent.

The Africa Medicines 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.

The Commission acknowledges with thanks the support of the African Union Special Envoy for the African Medicines Agency (AMA), Honourable Michel Sidibé and the high-level advocacy mission that contributed to the realization of the 15 ratifications that were needed to bring the treaty into force. The Commission additionally acknowledges the support of the African Union Development Agency (AUDA-NEPAD) and the World Health Organization (WHO) and all stakeholders whose efforts contributed to the achievement of this important milestone,” further added the Commissioner.

To date, seventeen member states of the African Union, that is: Algeria, Benin, Burkina Faso, Cameroon, Chad, Gabon, Ghana, Guinea, Mali, Mauritius, Namibia, Niger, Rwanda, Seychelles, Sierra Leone, Tunisia and Zimbabwe have ratified the Treaty for the Establishment of the African Medicines Agency and deposited the legal instrument of ratification to the Commission.

Only one-member state, namely Morocco, has ratified the treaty but is yet to deposit the instrument of ratification with the Commission.

In total, twenty-six member states including Algeria, Benin, Burundi, Cameroon, Chad, Cote d’Ivoire, Egypt, Gabon, Ghana, Guinea, Madagascar, Mali, Mauritius, Morocco, Niger, Rwanda, Republic of Congo, Saharawi Arab Democratic Republic, Senegal, Seychelles, Sierra Leone, Tanzania, Togo, Tunisia, Uganda and Zimbabwe have signed the treaty.

The African Union Commission continues to encourage all its member states to sign and ratify the Treaty for the Establishment of the African Medicine Agency in the interest of public health, safety and security.

The Commission shall proceed towards the establishment and full operationalization of the AMA at the earliest. It is to be recalled that on 04 August, 2021 the Commission invited member states to submit their expression of interest to host the headquarters of the African Medicines Agency.

In this regard, the Commission is in receipt of expression of interests from thirteen member states and preparations to commence the evaluation missions to determine seat of the Agency are currently on-going.

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