Regulatory Systems

African Medicines Agency

Towards an African Medicines Agency

The unanimous decision in 2019 by the African Union Assembly to adopt the treaty to establish an African Medicines Agency is a turning point to enhancing regulatory oversight and facilitating access to safe and affordable medicines across the continent.

AMA has the unique opportunity to become one of the most efficient and modern regulatory systems in the world. This opportunity can rapidly transform into reality, by using the experience gained from a decade of harmonization activities in the continent, learnings gained during the pandemic and the swift implementation of modern and innovative solutions.

The African Medicines Agency’s (AMA) long journey towards harmonization started in 2009 with the establishment of the African Medicines Regulatory Harmonisation Initiative (AMRH) and the involvement of many key partners across governments, civil society, and industry.

In 2019 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.

As of March 2020, the Treaty for the establishment of the AMA has been signed by fifteen (15) countries namely: Algeria, Benin, Chad, DRC, Ghana, Guinea, Madagascar, Mali, Morocco, Niger, Rwanda, Saharawi Arab Republic, Senegal, Seychelles, and Tunisia. While a minimum of fifteen (15) Member States are needed to ratify the AMA Treaty for AMA to come into force, only a handful of countries have ratified the Treaty at the end of 2020.

IFPMA acknowledges and supports the establishment of the AMA in order to:

  • Allow more focused resources for value-adding activities and making evidence-based scientific regulatory decisions;
  • Minimize administrative hurdles;
  • Allow for increased reliance based on harmonized regulatory requirements across Africa enabling acceleration and simplification of access to medicines;
  • Allow for technical back-up, work-sharing, synergies and collaboration ultimately ensuring overall optimization of the healthcare system.
  • Enable expanded and timely access to effective, safe, and quality medicines for patients

IFPMA appeals to all national regulators and healthcare stakeholders to meaningfully engage and advocate for AMA treaty ratification through important roles they play in their respective countries and ensure that the AMA becomes a reality.


Countries in Africa


Countries needed to ratify the Treaty


Adoption of Treaty to create AMA

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