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African Medicines Agency (AMA)

AMA will be established as a Specialized Agency of the African Union (AU) dedicated to improving access to quality, safe and efficacious medical products in Africa. The AMA Treaty was adopted by the AU Assembly on 11 February 2019 and a minimum of Fifteen (15) Member States are needed to ratify the AMA Treaty in their national parliaments, for AMA to come into force.

  • Vision
  • Mission
  • What is AMA's Role?
  • Organs of the AMA
  • Guiding Principles
  • Resources

AMA Vision

African People have Access to essential Medical Products and Technologies

AMA Mission

Provide Leadership in creating an enabling regulatory environment for Pharmaceutical Sector Development in Africa

What is AMA's role?

  • AMA will support the growth of local pharmaceutical production, a key objective of the Pharmaceutical Manufucaturing Plan for Africa (PMPA). It will further play a critical role in catalyzing trade in support of the Africa Continental Free Trade Area (AfCFTA).

  • AMA will evaluate medical products for the treatment of priority diseases as determined by the African Union.

  • It will also regularly inspect, coordinate and share information about products that are authorised for marketing.

  • AMA will coordinate joint reviews of clinical trial applications for vaccines and assessment of "highly complex" product dossiers such as bio-similars. AMA will also coordinate joint inspections of Active Pharmaceutical Ingredients (API) manufacturing sites.

  • AMA will collaborate with Regional Economic Communities (RECs) and National Medicines Regulatory Authorities  (NMRAs) in the identification of substandard and falsified medical products (SFs) and facilitate information sharing across countries.

  • By developing common standards and regulations, AMA will also be responsible for harmonising legislation.

Organs of the AMA

  1. The Conference of parties

  2. Governing Board

  3. The Secretariat

  4. Technical Committees

Guiding Principles

Guiding Principles of AMA

AMA Resources

AMA Brochure

     

African Medicines Agency (AMA) Brochure

     

AMA Infographics

AMA Infographics

The Future: AUDA-NEPAD African Medicines Agency

 

Video: The Future: AUDA-NEPAD African Medicines Agency

(English)

 

The Future: AUDA-NEPAD African Medicines Agency_video

Video: The Future: AUDA-NEPAD African Medicines Agency

(French)

 

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