African Medicines Regulatory Harmonisation(AMRH)


Medicines regulation helps to ensure that patients have access to quality, safe, and efficacious medicines being an important but neglected component of promotion and protection of public health. Investing in the African Medicines Regulatory Harmonization (AMRH) initiative provides an opportunity for strengthening regulatory capacity, cost-effective use of the limited financial and human resources, attainment of the three health-related Millennium Development Goals (MDGs), and promotion of trade and socioeconomic development for African countries and regions.

The objective of the African Medicines Regulatory Harmonization (AMRH) is to ensure that African people have access to essential medical products and technologies. AMRH is a programme of the African Union (AU) implemented as part of the Pharmaceutical Manufacturing Plan for Africa (PMPA). Under the theme “Strengthening of Health Systems for Equity and Development in Africa”, the AU Conference of Health Ministers (AUCHM) in April 2007 responded to the AU Assembly Decision 55 (Assembly/AU/Dec.55 (IV) taken during the Abuja Summit in January 2005 which mandated the African Union Commission (AUC) to develop the PMPA within the framework of the NEPAD.

The 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, redundant/duplicative processes, sluggish medicine registration processes and subsequent delayed 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.


Provide leadership in creating an enabling regulatory environment for pharmaceutical sector development in Africa

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