Since 2009, the Africa Union Development Agency (AUDA-NEPAD), in collaboration with partners, has been leading the African Medicines Regulatory Harmonization Initiative (AMRH).

The AMRH aims to improve the fragmented regulatory system for medical product registration in Africa by changing from a country-focused approach to a collaborative regional one.

The vision is to gradually move from 55 countries acting independently to the five Regional Economic Communities (RECs) supporting AMA.

AMA is a specialized agency of the African Union (AU) established to enhance the capacity of State Parties and Regional Economic Communities (RECs), to regulate and improve access to quality, safe and efficacious medicines, medical products and technologies in Africa. Additionally, it will coordinate the ongoing regulatory initiatives and systems in the continent.

As of 24 November 2023, thirty-three (33) AU Member States have signed the AMA Treaty while twenty-six (26) have ratified and deposited the legal instrument of ratification at the AU Commission.

The Treaty for the establishment of the AMA-Assembly Decision Assembly/AU/Dec.735(XXXII)-was adopted by the 32nd Ordinary Session of the Assembly on 11 February 2019, in Addis Ababa, Ethiopia.

On 10 June 2023, the Republic of Rwanda signed the AMA Headquarters Host Country Agreement abiding to host the Agency at its capital, Kigali.

Access to safe, effective, quality and affordable medicines, medical products and technologies-core pillars of the AU Agenda 2063 and Universal Health Coverage (UHC)-are at the centre of Africa's healthy and productive population.