Pharma Biz: African Union to come up with African Medicine Agency to harmonize drug regulation of member states

African Union (AU) is coming up with an African Medicine Agency (AMA) which will be tasked with cooperation and strengthening of healthcare activities to harmonize medicine regulation of member states of the Union in line with European Medicine Agency (EMA).

There are 55 countries in African Union. In August 2017 AU had come up with draft treaty for the establishment of AMA. Once the draft treaty is ratified by the member states, it will pave the way for setting up of AMA.

The main objective of AMA is to improve access to quality, safe and efficacious medical products on the continent through coordination and strengthening of ongoing initiatives to harmonize medicines regulation, promote cooperation and mutual recognition of regulatory decisions. Besides, it will be carrying out regulatory oversight of selected medical products and providing technical guidance to AU member states and Regional Economic Community (RECs) recognized by AU, pooling expertise and capacities and strengthening networking for optimal use of the limited resources available for regulatory authorities and complement and enhance the efforts of on-going harmonisation initiatives.

At the core, it will serve as a catalyst for stronger regulatory monitoring to check substandard medical products and improve competitiveness of medicines manufactured in AU countries for diseases affecting the African continent.

Original Article

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