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

The Treaty for the Establishment of the African Medicines Agency (AMA) entered into force as of 5th November 2021, thirty (30) 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 (Article 38, AMA Treaty)

AMA, the declaration of the African Union

“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 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.

The 26 states that have joined AMA

To date, seventeen (17) member states of the African Union (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.

One (1) member state, namely Morocco, has ratified the treaty but is yet to deposit the instrument of ratification with the Commission.

In total, twenty-six (26) member states (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 operationalisation 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 (13) member states and preparations to commence the evaluation missions to determine seat of the Agency are currently on-going.

About the African Medicines Agency (AMA)

The AMA Treaty was adopted by Heads of States and Government during their 32nd Ordinary Session of the Assembly on 11 February 2019 in Addis Ababa, Ethiopia.

The African Medicines Agency aspires to enhance capacity of State Parties and AU recognized Regional Economic Communities (RECs) to regulate medical products in order to improve access to quality, safe and efficacious medical products on the continent.

AMA shall build on the efforts of the African Medicines Regulatory Harmonization (AMRH) initiative (2009), which is led by the Africa Union Development Agency – the New Partnership for Africa’s Development (AUDA-NEPAD).

The AMRH initiative provides guidance to AU recognized Regional Economic Communities (RECs) and Regional Health Organizations (RHOs), to facilitate harmonization of regulatory requirements and practice among the national medicines authorities (NMRAs) of the AU Member States.

AMA will be the second specialized health agency of the African Union after the Africa Centres for Disease Control and Prevention (Africa CDC).

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