On 3 December 2021, the Republic of Uganda became the eighteenth (18th) African Union (AU) member state to deposit the instrument of ratification of the African Medicines Agency (AMA) at the AU Commission in Addis Ababa, Ethiopia. The Republic of Uganda ratified the Treaty on the 11 November 2021 in Kampala, Uganda.
Speaking at the signing occasion, H.E. Rebecca Amuge Otengo, Ambassador of Uganda to Ethiopia and the African Union noted that Uganda is committed to supporting the operationalization of the AMA for Africa to have a sovereign institute that shall prioritize the health and well-being of African citizens. “It is my pleasure to reiterate our commitment and continued support to the Commission in efforts to encourage more member states to sign and ratify the AMA Treaty.”
AMA will among other functions examine, discuss and/or express regulatory guidance on any regulatory matter within its mandate, either on its own initiative or at the request of the African Union, RECs or State Parties. The agency will also provide guidance on regulation of traditional medical products and provide advice on the marketing authorization application process for the priority drugs described by the States Parties or on the products proposed by the pharmaceutical laboratories.
To date, twenty-six (26) member states have signed the Treaty, nineteen (19) of these have ratified and eighteen (18) have deposited the instruments of ratification to the Commission. The 15th instrument of ratification was deposited at the African Union Commission on the 5th of October 2021 and the Treaty entered into Force (as per Article 38) of the Treaty on 5th November 2021. The Commission expects to have the operationalization of AMA in 2022.
The African Union Commission encourages all its member states to sign and ratify the Treaty for the establishment of AMA in the interest of public health, safety and security. The Treaty is available for signature at the Headquarters of the Commission in Addis Ababa, Ethiopia.
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).
Further information should be directed to:
1. Mohamed Salem Boukhari Khalil, Office of the Legal Counsel of the African Union Commission Tel: +251911405697; Email: KhalilM@africa-union.org
2. Dr. Margaret Agama-Anyetei, Ag. Director of Health and Humanitarian Affairs Directorate; Department of Health, Humanitarian Affairs and Social Development, AU Commission; Tel: +251115182211; E-mail: Agama-AnyeteiM@africa-union.org
For further media inquiries, please contact:
1. Ms. Dorothy Njagi | Strategic Communication Expert, Directorate of Health and Humanitarian Affairs | Department of Health, Humanitarian Affairs and Social Development, African Union Commission | Mobile: +251940559950 | E-mail: njagid@africa-union.org
2. Mr. Gamal Eldin Ahmed A. Karrar | Senior Communication Officer | Information and Communications Directorate | E-mail: GamalK@africa-union.org
Information and Communication Directorate, African Union Commission I E-mail: DIC@africa-union.org
Web: au.int.int | Addis Ababa, Ethiopia | Follow Us: Facebook | Twitter | Instagram | YouTube
