Regulatory system strengthening, harmonisation and support to the operationalisation of AMA

Access to quality-assured, safe and efficacious medical products for the prevention, detection and treatment of diseases is an essential component of any public health system. However, despite Africa's high disease burden and mortality from preventable and curable diseases, unavailability and unaffordability of good quality, safe and efficacious medical products cripple the health system response for both communicable and non-communicable diseases. National Regulation Authorities (NRAs) are essential for unblocking bottlenecks to timely access for the needed medical products and technologies. The African Medicines Regulatory Harmonization (AMRH) programme was initiated in 2009 to support countries to address challenges faced in regulatory systems including limited human and institutional capacity, lack of comprehensive legal frameworks giving a mandate to the governments to regulate medical products and technologies, inconsistent regulatory processes, and variable technical standards and guidelines that do not meet international standards. The progress of the AMRH led to the establishment of the African Medicines Agency (AMA) which will be anchored by regional regulatory harmonization activities. This project is therefore aimed at strengthening regulatory systems and harmonization in Africa for improved access to quality, safe and efficacious medical products by strengthening regional regulatory harmonization and supporting the operationalization of the AMA.