12 August 2021. The Republic of Benin becomes the tenth (10th) Member State to deposit the instrument of ratification of the African Medicines Agency (AMA) to the Commission of the African Union (AU) in Addis Ababa, Ethiopia. The Republic of Benin ratified the Treaty for the establishment of AMA on 30 June 2021 in Cotonou, Benin.

The ratification and deposit of the instrument follows a high-level advocacy engagement between H.E. President Patrice Talon of the Republic of Benin with Honourable Michel Sidibé the African Union Special Envoy for the AMA on 03 May, 2021 in Cotonou, Benin.

AMA will be the second specialized health agency of the African Union after the Africa Centres for Disease Control and Prevention (Africa CDC). The agency will among other functions monitor, evaluate and assess the comprehensiveness of national medical products regulatory systems with the view to recommend measures that will improve efficiency and effectiveness. AMA will also evaluate and decide on the selected medical products, including complex molecules, for treatment of priority diseases/conditions as determined by the African Union, and the World Health organization (WHO).

AMA will further provide technical assistance and resources, where possible, on regulatory matters to State Parties that seek assistance and pool expertise and capacities to strengthen networking for optimal use of the limited resources available.
In all its functions AMA shall adhere to international standards of quality management and create the conditions for continous improvement of its regulatory practices and those of national medicines authorities (NMRAs) of Member States of the African Union.
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 provide support for the improvement of weak regulatory systems. 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 inititiave 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.
Fifteen (15) member states have ratified the AMA Treaty. The AMA Treaty will enter into Force 30 days upon the deposit of the 15th instrument of ratification at the Commission.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.

Further information should be directed to:

1. Office of the Legal Counsel of the African Union Commission
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

For further information contact:

Directorate of Information and Communication | African Union Commission
E-mail: dic@africa-union.org I Web Site: www.au.int I Addis Ababa | Ethiopia

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