The Republic of Zimbabwe becomes the nineteenth (19th) African Union (AU) Member State to sign the Treaty for the establishment of the African Medicines Agency (AMA) on 16 March 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.
Speaking during the official signing of the Treaty, H.E. Amira Elfadil Mohammed, Commissioner for Health, Humanitarian Affairs and Social Development, at the African Union Commission, who received the delegation from Zimbabwe underscored the importance of establishing AMA inorder to improve the production and harmonization of pharmaceutical products on the continent. She noted that the looming COVID-19 pandemic, is an opportunity to accelerate the establishment of AMA and it is a top priority for the Commisision inorder to bridge the gap in pharmaceutical industries.
The Ambassador of Zimbabwe to Ethiopia and the African Union H.E. Taonga Mushayavanhu reiterated the importance of AMA in synchronizing the pharmaceutical systems in establishing a mechanism of controlling the counterfeit medicines on the continent. In addition, he made a commitment to swiftly move to the next stage of ratification of the AMA Treaty.
The signing of the Treaty is a step forward in realizing the establishment of the African Medicines Agency (AMA) out of the desire of the Heads of States and Government to use a continental institutional, scientific and regulatory resources to improve access to safe, efficacious and quality medicines. This is in addition to the establishment of the African Medicines Regulatory Harmonization (AMRH) in 2009, under the management and guidance of the Africa Union Development Agency – the New Partnership for Africa’s Development (AUDA-NEPAD) working with 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. Further, driven by the aspiration in meeting internationally acceptable standards and providing a favourable regulatory environment for pharmaceutical research and development, local production and trade across countries on the African continent.
AMA will among other functions designate, promote, strengthen, coordinate and monitor Regional Centres of Regulatory Excellence (RCOREs) with a view to developing the capacity of medical products regulatory professionals. The agency will also coordinate and collaborate, where required and on a regular basis, the inspection of drug manufacturing sites, including the regulatory oversight and safety monitoring of medical products, as determined by State Parties and/or the AMA, and make reports available to State Parties. AMA will also promote cooperation, partnership and recognition of regulatory decisions, in support of regional structures and National Medicines Regulatory Authorities (NMRAs), that takes into account mobilization of financial and technical resources to ensure the sustainability of the AMA.
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 six member states at the Commission.