Overview

The East Africa Community Medicines Regulatory Harmonization Programme is a regional programme that was launched on 30th March 2012 by the EAC Council of Ministers in Arusha, United Republic of Tanzania. The goal of the programme is to facilitate access to safe, efficacious and quality essential medicines, vaccines and medical devices for treatment, management and diagnosis of conditions of public health importance. The programme 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:

1. Implement an agreed Common Technical Document (CTD) for registration of medicines in EAC Partner States;

2. 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;

3. Implement a quality management system in each of the EAC Partner States’ NMRA;

4. Build regional and national capacity to implement medicines regulatory harmonization in the EAC region;

5. Create a platform for information sharing on the harmonized medicines registration system to key stakeholders at national and regional levels; and

6. 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.