The Republic of Burundi Signs the Treaty for the Establishment of the African Medicines Agency
The Republic of Burundi becomes the twentieth (20th) African Union (AU) Member State to sign the Treaty for the establishment of the African Medicines Agency (AMA) on 11 June 2021, at the AU Commission in Addis Ababa, Ethiopia. The AMA Treaty was adopted by Heads of States and Government during their 32nd Ordinary Session of the Assembly on 11 February 2019 in Addis Ababa, Ethiopia.
Mme Cisse Mariam Mohamed, the Director, Health, Humanitarian Affairs & Social Development (HHS), received the delegation from the Republic of Burundi. She underscored that AMA shall be instrumental in ensuring the continent has not only a strong medicines regulatory agency but also it shall promote local manufacturing of pharmaceutical products on the continent. “As evidenced by the challenges Africa is facing in accessing the COVID-19 vaccine, it is the high time that we come together as a continent to fast track the ratification of AMA in order to have an African Pharmaceutical Industry that provides safe and affordable medicines,” she said.
The Ambassador of Burundi to Ethiopia and to the African Union, H.E. S.E Joël Nkurabagaya reiterated the importance of AMA in ensuring access to safe and affordable medicines in the continent. He committed to champion the ratification of the AMA Treaty by Burundi for it to be amongst the 15 Member States to ratify.
The signing of the Treaty by Burundi demonstrates the commitment by Member States in making progress towards the establishment of the African Medicines Agency (AMA). One of the greatest challenges on the continent has been the lack of availability of medicines and vaccines during public health emergencies of international concern, in particular, during the ongoing COVID-19 pandemic. Therefore, quality-assured, safe and efficacious medical products are fundamental to the health and safety of the population of Africa.
The African Medicines Agency aspires to provide support for the improvement of weak regulatory systems. AMA shall build on the efforts of the African Medicines Regulatory Harmonization (AMRH) initiative (2009), which is led by the Africa Union Development Agency – the New Partnership for Africa’s Development (AUDA-NEPAD). The AMRH inititiave provides guidance to AU recognized Regional Economic Communities (RECs) and Regional Health Organizations (RHOs), to facilitate harmonization of regulatory requirements and practice among the national medicines authorities (NMRAs) of the AU Member States.
AMA will be the second specialized health agency of the African Union after the Africa Centres for Disease Control and Prevention (Africa CDC). The agency will among other functions coordinate and strengthen ongoing initiatives to harmonize medical products regulation and enhance the competence of Good manufacturing practices (GMP) inspectors to do so. AMA will also coordinate the collection, management, storage and sharing of information on all medical products including substandard and falsified medical products, with all its State Parties and globally.
In addition, AMA will coordinate joint reviews of applications for the conducting of clinical trials and provide technical support in quality control of drugs at the request of Member States which do not have the structures to carry out these examinations/controls/ checks.
The African Medicine Agency, will enter into force once ratified by fifteen African Union Member States. To date, the instruments of ratification have been deposited by seven Member States at the Commission.
Official website of the African Union (www.au.int), article accessible at https://au.int/fr/node/40412, published on June 11th, 2021, accessed on June 14th, 2021.