Objectives of the EAC-MRH Programme
The East African Community (EAC) Medicines Regulatory Harmonization is a regional programme and is part of the continental initiative, the “African Medicine Regulatory Harmonization (AMRH)” whose aim is to address the concerns of lack of standardized approaches in regulation of medicine, vaccines and medical devices.
The main objective is to:
- Implement an agreed Common Technical Document (CTD) for registration of medicines in EAC Partner States;
- Implement a common information management system for medicines registration in each of the EAC Partner States’ National Medicines Regulatory Authority (NMRA) which is linked in all Partner States and EAC Secretariat;
- Implement a quality management system in each of the EAC Partner States’ NMRA;
- Build regional and national capacity to implement medicines regulatory harmonization in the EAC region;
- Create a platform for information sharing on the harmonized medicines registration system to key stakeholders at national and regional levels; and
- Implement a framework for mutual recognition of medicines registration based in accordance with Article 118 of the Treaty for the establishment of the East African Community.