The African Medicines Agency (AMA) is a proposed specialised agency of the African Union (AU) intended to facilitate the harmonisation of medical regulation throughout the African Union. Following a similar model to that of the European Medicines Agency, it is intended to have a wide scope covering medicines, traditional medicine, and medical devices. The AMA is the latest step in efforts by the AU and regional African bodies to improve medical capacity in the continent. Such efforts are intended to address a deficiency in drug production and challenges posed by counterfeit and substandard products. Once it is created, it is expected that the AMA will supervise and absorb roles currently carried out by other bodies, such as regional harmonisation efforts and pan-AU creations such as the African Medicines Regulatory Harmonization (AMRH) initiative and the African Vaccines Regulatory Forum (AVAREF). The Treaty for the Establishment of the African Medicines Agency was adopted by the AU in February 2019. It came into effect on 5 November 2021, after ratification from the 15th AU member states, Cameroon. The headquarters of the AMA will be located in Rwanda. History The proposed African Medicines Agency (AMA) is a continuation of existing medical regulatory harmonisation efforts in the continent. Across Africa it is estimated that only 3% of required drugs are produced. The roughly 375 medicine manufacturers on the continent produce only 10-30% of drugs used in Africa. Another challenge is the proliferation of substandard and counterfeit medical products. Porous borders make it easy for such products to move within the continent, and there is significant variation in the quality of current medical regulation between countries in the African Union (AU). While every country except the Sahrawi Arab Democratic Republic has a National Medicines Regulatory Authorities (NMRAs), many are unable to carry out many expected essential functions. The WHO considers 90% of African countries to have minimal to no medical regulatory capacity. Many medicines are not distributed to some countries due to the length of time needed to receive regulatory approval. In 2005 the AU decided to create a “Pharmaceutical Manufacturing Plan for Africa”. Under this the African Medicines Regulatory Harmonization (AMRH) initiative was established in 2009, and fully launched in 2012. The AMRH represented the first time that NMRAs within Africa worked together. During the 1st African Ministers of Health meeting, which ran on 14–17 April 2014 in Luanda, member states were requested to allocate