A critical AU Model Law aimed at harmonizing medical products regulatory systems in Africa was endorsed by African Heads of State and Government at the January 2016 AU Summit in Addis Ababa, Ethiopia. The AU Model Law will contribute towards accelerate the regulation of safe, quality and affordable medical products and technologies in Kenya.

In 2015, the inaugural IGAD Member States NMRA’s meeting was held in Addis Ababa, Ethiopia. Kenya successfully participated and signed the Call for Action to implement a regional Medicines Regulatory Harmonization (MRH) programme. A follow up meeting was convened in 2016 and agreed to establish an IGAD MRH Steering Committee, Technical Working Groups (TWG’s) and a Coordination Unit.

The EAC-MRH programme conducted a Joint Dossier Assessment of 8 medicinal products in Entebbe, Uganda in 2015; Four (4) of which were already registered by the Pharmacy and Poisons Board of Kenya. Phase two of the EAC-MRH programme has expanded to include drug safety (pharmacovigilance) strengthening; clinical trials oversight; regulation and quality assurance of medical devices including diagnostics; and harmonization of regulation of vaccines.

Kenya has a designated RCORE specializing in Pharmacovigilance called Pharmacy and Poisons Board (PPB) of Kenya. RCOREs are institutions with specific academic and technical regulatory science expertise and training capabilities capable of producing regulatory workforce in Africa.

NEPAD Planning and Coordinating Agency on AMRH

African Medicines Regulatory Harmonisation