This led to the development of the African Medicines Regulation Harmonization (AMRH) initiative1 which was launched in 2009 within the PMPA Framework to facilitate the creation of an enabling regulatory environment for pharmaceutical sector development in Africa through harmonisation of regulation by the Member States through the Regional Economic Communities (RECs). The ultimate vision is African populations having access to essential medical products and health technologies. It was envisioned that through harmonisation, the regulatory capacity challenges that the continent is facing which imped access to medical products and technologies will be surmounted.