Three AU Member States signed the Treaty for the establishment of the African Medicines Agency (AMA)

Share:

February 09, 2020

9 February 2020, Addis Ababa, Ethiopia: On the margins of the 33rd AU Summit, the Republic of Guinea, the Republics of Seychelles and the Republic of 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.

Note to Editors:

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.
Member states who are members of the Conference of the Party to the Treaty, shall be invited to put in an offer to host the Agency. Following an assessment of each countries bid to host, the report shall be presented to the Assembly of Heads of State and Government for a decision on the hosting of the Agency.

The main purpose of AMA is to:

i. Coordinate on-going regulatory systems,

ii. Strength and harmonize efforts of the African Union-recognized RECs, RHOs and Member States;

iii. Provide regulatory guidance; and

iii. Complement and enhance collaboration and contribute to improving patients’ access to quality, safe and efficacious medical products and health technologies on the continent.

The AMA Treaty has taken into consideration key AU Decisions, Declarations and Policy Frameworks: including The 55th Decision of the African Union (AU) {Assembly /AU/Dec.55 (IV)} taking during the Abuja Summit 2005 requested the AU Commission to develop a Pharmaceutical Manufacturing Plan for Africa (PMPA) within the framework of the New Partnership for Africa’s Development (NEPAD), now African Union Development Agency (AUDA) aimed to improve access to good quality, safe and efficacious medical products and health technologies for the African population and the 19th ordinary session decision of the Assembly - {Assembly AU/Dec.442 (XIX)}, Pillar II also requested the AU Roadmap on Shared Responsibility and Global Solidarity for AIDS, Tuberculosis and Malaria response in Africa on access to medicines aiming to accelerate and strengthen regional medicines regulatory harmonization initiatives and lay the foundation for a single African regulatory agency.

The Africa Medicines Agency shall also build on the strengthened capacity of medical products regulation in Africa and the harmonization of regulatory systems, within the context of the African Medicines Regulatory Harmonization (AMRH) Initiative.
As of today, 14 member states, namely: Algeria, Benin, Chad, Ghana, Guinea, Madagascar, Mali, Morocco, Niger, Rwanda, Saharawi Arab Democratic Republic, Senegal, Seychelles, and Tunisia are amongst the first countries to sign the Treaty, and only Rwanda, has deposited its instrument of ratification at the office of the Chairperson of the Africa Union Commission.

For information regarding the Treaty, please contact:

The Office of the Legal Consul of the African Union Commission
Dr. Margaret Agama-Anyetei, Head of Division for Health, Nutrition and Population; Social Affairs Department; AU Commission; Tel: +251115162211; E-mail: Agama-AnyeteiM@africa-union.org