About

African Medicines Regulatory Harmonization (AMRH) programme started in 2009 as a response to addressing challenges faced by National Medicine Regulatory Authorities (NMRAs) in Africa. These challenges include; weak or non-coherent legislative frameworks, sluggish medicine registration processes and subsequent delayed approval decision, inefficiency and limited technical capacity, among others. This situation translates in to poor access to priority essential medicines by patients and is a contributing factor to over-priced medicines.

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REGIONAL ECONOMIC COMMUNITIES

The AMRH Initiative has so far been implemented in 5 RECs namely, East African Community (EAC), Southern African Development Community (SADC), the Economic Community of West African States(ECOWAS), the Economic…

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NATIONAL MEDICINES REGULATORY AUTHORITIES

The AMRH is being implemented in the 55 National Medicines Regulatory Authorities (NRAs) in Africa. Some of these authorities function as departments in their Ministries of Health

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HARMONISING AND REGULATING MEDICINES IN AFRICA

The Pharmaceutical Manufacturing Plan for Africa (PMPA) led to the establishment of the AMRH Initiative in 2009 to address weak, outdated,and fragmented regulatory systems on the African continent. AMRH, led by the African Union Development Agency-NEPAD (AUDA-NEPAD) was established in collaboration with the National Regulatory Agencies (NRAs), Regional Economic Communities (RECs), the African Union Commission (AUC), Pan African Parliament (PAP), the World Health Organization (WHO), the Bill and Melinda Gates Foundation (BMGF), the World Bank and other development partners.

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