African Medicines Agency and a new African regulatory ecosystem

The African medicines regulatory landscape is evolving rapidly. The African Medicines Agency (AMA) is being established as a Specialised 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 Member States were needed to ratify the AMA Treaty in their national parliaments, for AMA to come into force. To date 26 countries have ratified and deposited the ratification instrument with the African Union Commission (AUC), with a number of others in the process of doing so. It is expected that over time, more countries will ratify and deposit the instrument.