- Mots-clés > African Medicines Agency (AMA)
- Mots-clés > African Medicines Regulatory Harmonization (AMRH)
- Mots-clés > harmonization of medicines regulation
- Mots-clés > International Coalition of Medicines Regulatory Authorities (ICMRA)
- Mots-clés > medicines registration systems
- Mots-clés > medicines regulation
- Mots-clés > National Medicines Regulatory Authority (NMRA)
- Mots-clés > Pharmaceutical Manufacturing Plan for Africa (PMPA)
- Mots-clés > regulatory authority - medicines
- Mots-clés > regulatory harmonization
- Mots-clés > autorités de réglementation pharmaceutique
(2015; 4 pages)
In response to the declarations of the African Heads of State and Government Assembly/AU/Decl.2 (XIX) as well as the decisions by the World Health Organization WHO Regional Committee for Africa, the First African Ministers of Health Meeting jointly convened by the African Union Commission (AUC) and the World Health Organization (WHO) in Luanda, Angola, 14-17 April 2014 endorsed key milestones for the establishment of the African Medicines Agency (AMA). The milestones include; decisions by the AU Summit of Heads of State and Government, designation of host institution/country, approval of the governing body, appointment of staff and allocation of resources and launch of the AMA (AUC/WHO/2014/Doc.2). The Ministers of Health committed to prioritize investment for regulatory capacity development; to pursue the efforts towards convergence and harmonization of medical products regulation in Regional Economic Communities (RECs) and to allocate resources for the operationalization of the AMA. Ministers of Health also requested the AUC and WHO in collaboration with relevant stakeholders to establish a Task Team that will facilitate the implementation of the agreed milestones with due regard to regional representation and skills required to meet the mandate as noted.
The AMA is intended to be an organ of the AU, legally mandated by Member States. It will provide a platform for coordination and strengthening of on-going initiatives to harmonize medicines regulation. It will also serve the purpose of pooling expertise and capacities and strengthening networking for optimal use of the limited resources available. AMA will therefore provide guidance and complement and enhance the efforts of the RECs towards harmonization of medical products regulation. By enhancing the regulatory environment, AMA will contribute to enhancing access to medical products.