Supporting the implementation of the African Medicines Regulatory Harmonization (AMRH) Programme

The African Medicines Regulatory Harmonization (AMRH) Programme, a collaborative effort of a consortium of partners (Link), supports African countries and regions in building effective regulatory networks for medicines inside established Regional Economic Communities (RECs) in order to improve access to essential medicines.

1. Supporting the Medicines Regulatory Harmonization Initiatives in the African Regional Economic Communities

The first REC to secure funding under the AMRH Programme was the East African Community (EAC) (Link). The EAC-MRH initiative for registration of generic medicines was launched in March 2012. The initiative aims to accelerate access to medicines for people in the EAC member states by harmonising their national medicine-registration systems. Common guidelines have been developed and are in the process of being implemented in the following four subject areas:

  • Medicines Evaluation and Registration (MER)
  • Good Manufacturing Practice (GMP)
  • Quality Management Systems (QMS)
  • Information Management Systems (IMS)

Swissmedic is collaborating with the WHO to support the EAC-MRH initiative as well as the harmonisation initiatives launched by other RECs, such as the Medicines Regulatory Harmonization initiatives in West Africa (WA-MRH) and in Southern Africa (SADC-MRH). Swissmedic contributes to the development of technical guidelines, to their implementation and maintenance and to capacity-building programmes and activities in the four areas listed above.

2. Supporting the African Medicines Medical Harmonisation Partnership Platform

At a continental level, Swissmedic started its support for the AMRH Programme in 2017. In February 2018, the African Union Development Agency (AUDA-NEPAD), the political arm of the African Union, issued a call for expression of interest to join the African Medicines Regulatory Harmonization Partnership Platform (AMRH-PP). The AMRH-PP is a coordination mechanism in efforts to effectively group, foster transparency and supervise the various partners and interest groups that support the AMRH Programme. Since August 2018, Swissmedic has been an official technical partner (member) of the AMRH-PP and attends the Steering Committee meetings of the AMRH as an observer.

In 2022, Swissmedic was elected Chair of the Technical Partners Group (TPG) at the AMRH PP. The aim of this group is to coordinate the technical resources of the various partners and distribute them efficiently and according to the needs of the players in the various areas of implementation at national, regional and continental level.

Since 2022, Swissmedic has been an official member of the WHO Coalition of Interested Parties (CIP), whose regional working group in Africa is the AMRH PP. The aim of the CIP is to develop and promote a consistent strategic and coordinated approach to strengthen national and regional regulatory systems in the AMRH PP countries and regions in order to improve access to safe, effective, high-quality medical products.

3. WHO Global benchmarking for evaluation of national regulatory systems

Since 1997 the WHO has assessed regulatory systems using a set of indicators designed to evaluate the regulatory programme for vaccines. With the latest Revision VI, the current GBT is now the first “global” tool for benchmarking regulatory systems, replacing all tools previously used by the WHO. Swissmedic experts support the WHO Benchmarking Programme by contributing expertise on request to its missions.