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 Rwanda.
After the successful establishment of the East African Countries (EAC) Medicines Regulatory Harmonization (MRH) programme in 2012, Rwanda participated in the development and subsequent adoption of harmonized technical guidelines by the EAC Council in 2014 and publication of a compendium for EAC member states. Two pilot projects: the World Health Organization Medicines Prequalification Program (WHO-PQP) and the EAC Joint Assessments and Inspections ensured that Rwanda participated in the approval of 5 and 7 products in 2011 and 2013 respectively. 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.
In 2015, the EAC-MRH programme developed a Joint Dossier Assessment of 8 medicinal products in Entebbe, Uganda and Rwanda was a participating member.
