The Republics of Guinea, Seychelles andn Niger signed the Treaty for the establishment of the African Medicines Agency (AMA) to raise the of signatories number for the Treaty to 14 countries.
The AMA Treaty was adopted by Heads of State and Government during their 32nd Ordinary Session of the Assembly on 11 February 2019 in Addis Ababa, Ethiopia. Member States are able to sign the treaty at the Headquarters of the Commission in Addis Ababa, Ethiopia.
The African Medicines Agency, will enter into force once ratified by fifteen African Union Member States will serve as the continental regulatory body that will provide regulatory leadership, to ensure that there are harmonized and strengthened regulatory systems, which govern the regulation of medicines and medical products on the African continent.
The Agency will regulate the access to safe, effective, good quality and affordable essential medicines and health technologies. AMA will do this through coordination of on-going regulatory systems, strengthening and harmonizing efforts of the AU Commission (AUC), Regional Economic Communities (RECs), Regional Health Organizations (RHOs) and member states, providing regulatory guidance.
The African Medicines Agency (AMA) is a Specialized Agency of the African Union with its own rules, membership and resources to enhance the capacity of State Parties and Regional Economic Communities (RECs), to regulate medical products in order to improve access to quality, safe and efficacious medical products on the continent. The Treaty shall enter into Force 30 days after the deposit of the 15th instrument of ratification and ascension.