African Medicines Regulatory Harmonization
What is AMRH?
African Medicines Regulatory Harmonization (AMRH) programme started in 2009 as a response to addressing challenges faced by National Medicine Regulatory Authorities (NMRAs) in Africa. These challenges include; weak or non-coherent legislative frameworks, sluggish medicine registration processes and subsequent delayed approval decision, inefficiency and limited technical capacity, among others. This situation translates in to poor access to priority essential medicines by patients and is a contributing factor to over-priced medicines.
The aim of the programme is to facilitate and coordinate the harmonization of medicines regulation and improve access to quality, safe, efficacious and affordable medicines in Africa as part of the broader African Union Framework on Pharmaceutical Manufacturing Plan for Africa (PMPA). To achieve this aim, AMRH works towards improving medicine registration processes and operational inefficiencies, thereby reducing registration times whilst enhancing the quality of the registration decision. The programme is implemented under the Industrialization, Science, Technology and Innovation unit of the NEPAD Agency, which is the implementation and technical arm of the African Union (AU). AMRH also contributes to the objectives of the Science, Technology, and Innovation Strategy for Africa (STISA) – 2024, which was endorsed by the AU Assembly in 2014 to shape Africa’s socio-economic development.
- To ensure that African people have access to essential medical products and technologies.
- To enable access to medical devices and diagnostics of assured quality, safety and performance across Africa.
- To establish a harmonized framework for regulation of medical devices including in vitro diagnostics in Africa based on the WHO global model for Medical Devices Regulatory Framework Model.
- This procedure will give marketing authorization in ECOWAS Member State(s).
What We Do
The AMRH programme provides leadership and works towards creating a collaborative network of regional, sub-regional and national partners with a common goal of creating an enabling environment for pharmaceutical sector development in Africa. AMRH’s work is guided by the AU Pharmaceutical Manufacturing Plan for Africa (PMPA) framework.
There are four main focus areas of the AMRH programme as follows:
- Harmonizing policies and regulatory frameworks of member states
- Enhancing human and institutional capacity for regulation of medical products and technologies.
- Facilitating and coordinating research and knowledge management on medicines regulation at country, regional and continental levels.
- Effective alignment and coordination of regulatory activities with the AMRH Framework and the African Medicines Agency (AMA).
Where we Work
The programme is currently operating through Regional Economic Communities (RECs) which include the following:
- East African Community (EAC).
- Economic Community of West African States/West African Economic and Monetary Union (ECOWAS/UEMOA).
- Southern Africa Development Community (SADC)
- Economic Community for Central African States (ECCAS) in collaboration with the Organization for Coordination of the Fight Against Endemic Diseases in Central Africa (OCEAC) and Central African Economic and Monetary Union (CEMAC)
- Intergovernmental Authority on Development (IGAD).
- Community of Sahel-Saharan States/Arab Maghreb Union (CEN-SAD/AMU).
- Common Market for Eastern and Southern Africa (COMESA).
This coverage represents a total of 33 countries. The programme seeks to expand and partner with strategic stakeholders to extend coverage to all African countries.
ECOWAS MRH Programme
The West Africa Medicines Regulatory Harmonization (MRH) programme was launched in 2015 in Accra, Ghana. Member States participated in the establishment of the joint MRH Project Steering Committee and formation of seven Technical Working Groups (TWG’s). The TWG’s are tasked with developing technical guidelines of the MRH programme. In addition, a joint framework of collaboration between WAHO and WAEMU has been agreed upon.
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.
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.
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 New Partnership for Africa’s Development NEPAD (now 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 has been attending the Steering Committee meetings of the AMRH as an observer.
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 to its mission in sub-Saharan Africa.