A new video is available about the African Union (AU) Model Law by the African Medicines Regulatory Harmonisation Programme (AMRH). AU Heads of State and Government endorsed the Model Law in Addis Ababa, Ethiopia in January of 2016. This video describes the Model Law and how AU Member States can go about using it. The Model Law is the outcome of partnership between the NEPAD Agency, the African Union Commission (AUC), Pan-African Parliament (PAP) and other key cooperating partners.
The African Medicines Regulatory Harmonization (AMRH) initiative is a programme of the African Union (AU) implemented as part of the Pharmaceutical Manufacturing Plan for Africa (PMPA). The programme started in 2009 as a response to addressing challenges faced by National Medicine Regulatory Authorities (NMRAs) in Africa which include; weak or non-coherent legislative frameworks, sluggish medicine registration processes and subsequent delayed approval decision, inefficiency and limited technical capacity, among others. The work of AMRH is guided by three focus areas: policy alignment, regional integration and harmonization, and human and institutional capacity development.
The programme works in collaboration with the AUC, Pan-African Parliament (PAP), World Health Organization (WHO), Bill and Melinda Gates Foundation, World Bank (WB), UK Department for International Development (DFID) and US Government-PEPFAR and Global Alliance for Vaccines and Immunization (GAVI). The AMRH Strategic Plan defines the strategic direction for the medicines harmonization agenda in Africa and provides direction to advance the development of the pharmaceutical sector and provides guidance in monitoring and evaluation.