African Medicines Regulatory Harmonisation (AMRH)

Ensuring availability of safe, good quality and reasonably priced medicines has been a challenge for many African countries. This is mainly due to non-existent, weak or outdated legal frameworks. As a result, most of the national medicines regulatory authorities (NMRAs) have limited capacity to approve medicines in a timely manner and to ensure acceptable quality, safety and efficacy standards.

The objective of the African Medicines Regulatory Harmonisation Programme (AMRH) is to establish and improve standards and requirements related to the regulation of and access to safe, high-quality medicines for the African population. 

Its overall aim is to establish - in partnership with the African Union Commission and the World Health Organization - the African Medicines Agency, which will operate under the authority of AMRH. The agency will oversee the registration of a selected list of medicines and coordinate regional harmonisation systems on the continent. African health ministers have taken the lead on the project since a meeting held in Luanda in April 2014.

 

DID YOU KNOW?
In a pilot demonstration project conducted in March 2014, the EAC Member Countries jointly inspected and registered two antimalarial drugs and three generic pharmaceuticals in less than one year. The procedure was completed 30 to 40 per cent faster than usual, resulting in significant cost and time savings.

Ensuring availability of safe, good quality and reasonably priced medicines has been a challenge for many African countries. This is mainly due to non-existent, weak or outdated legal frameworks. As a result, most of the national medicines regulatory authorities (NMRAs) have limited capacity to approve medicines in a timely manner and to ensure acceptable quality, safety and efficacy standards. Frequent delays and lack of transparency in the review process have also resulted in limited availability of medicines that are often highly priced and out of reach for the majority of Africans. This is further compounded by the fact that registration of medicines is a complex process which requires submission of a lot of scientific information from applicants (potential investors) with consequent need for expertise to conduct assessment and review of the respective applications from the NMRAs. 

The objective of the African Medicines Regulatory Harmonisation Programme (AMRH) is to establish and improve standards and requirements related to the regulation of and access to safe, high-quality medicines for the African population.

Its overall aim is to establish - in partnership with the African Union Commission and the World Health Organization - the African Medicines Agency, which will operate under the authority of AMRH. The agency will oversee the registration of a selected list of medicines and coordinate regional harmonisation systems on the continent. African health ministers have taken the lead on the project since a meeting held in Luanda in April 2014.

Results:

Decisive actions were taken to fight Ebola in the countries worst hit by the virus. The NEPAD Agency led efforts to mobilise African countries and establish a favourable environment for conducting clinical trials to test potential Ebola vaccines and other forms of therapy. It is expected that the joint reviews in the two regions will not only fast-track the approval process for the vaccine trials but also serve as a mechanism for strengthening regulatory systems and ethical standards in Africa.

AMRH in collaboration with the AUC and Pan African Parliament is developing a Model Law on medical products regulation and harmonisation in Africa. The AU Model Law will serve as a tool that will assist Member Countries to enact and review their existing laws in line with acceptable standards to ensure more effective regulation of medical products. It is not an abiding document but should rather be considered as a guide to regulate and harmonise medicines in Africa. The Model Law is expected to be adopted at the African Union Summit in January 2016.

AMRH has launched the Regional Centres of Regulatory Excellence Initiative to fill the human resource gaps experienced by NMRAs and the pharmaceutical industry. The institutions will provide academic and technical training in regulatory science, exchange programmes and operational research.

 

Action Plans

The document aims to detail the rationale and content of the AMRH Strategic Plan 2016-2020. It consists of several parts and sections; the first addressing achievements, challenges and lessons learned in the implementation of the AMRH Strategic Plan 2011-2015. The second part covers strategic...

This Business Plan addresses a complex industry and covers a diverse range of contexts across our 54 member states. Strengthening our ability to produce high quality, affordable pharmaceuticals across all essential medicines will contribute to improved health outcomes
...

This plan will assist in providing a clear vision and mission, strategic objectives and indicators that will be used to assess performance of the AMRH initiative and its impact on strengthening the African regulatory capacity and consequently increasing access and improve the quality, safety and...

Brochures

About Southern Africa Tuberculosis and Health Systems Support Project
The Southern Africa Tuberculosis and Health Systems Support Project is a World Bank (WB) funded regional project launched in 2016 with the aim of strengthening the health sector’s response...

The PMPA proposes that the promotion of industrial development and the safeguarding and protection of public health are not mutually exclusive priorities and that the production of quality medicines and the development of an internationally GMP compliant industry in Africa are...

Decisions/Declarations

African Union (AU) Model Law on Medical Products Regulations that was officially endorsed by the AU Heads of State and Government in Addis Ababa, Ethiopia in January of 2016. The AU Model Law was developed as a result of a partnership between the African Union Commission (AUC), NEPAD Agency, Pan...

Infographics

The Southern African Tuberculosis and Health Systems Support (SATBHSS) project was launched in Maputo, Mozambique in December of 2016. The project is funded by the World Bank (WB) and implemented in four (4) Southern African Development Community (SADC) countries; Zambia, Malawi, Mozambique and...

The Southern African Tuberculosis and Health Systems Support (SATBHSS) project was launched in Maputo, Mozambique in December of 2016. The project is funded by the World Bank (WB) and implemented in four (4) Southern African Development Community (SADC) countries; Zambia, Malawi, Mozambique and...

7 Things you need to know about the African Union (AU) Model Law on Medical Products Regulation

The overall goal of the 3rd Biennial Scientific Conference on Medical Products Regulation in Africa is to review progress and deliberate on actions for sustaining the momentum for regulatory systems strengthening and harmonisation in Africa. The theme for the conference is “Sustaining the...

The Southern African Tuberculosis and Health Systems Support (SATBHSS) project was launched in Maputo, Mozambique in December of 2016. The project is funded by the World Bank (WB) and implemented in four (4) Southern African Development Community (SADC) countries; Zambia, Malawi, Mozambique and...

As part of its mandate to strengthen regulatory capacity development in Africa, the NEPAD Agency through its AMRH programme has designated 11 Regional Centres of Regulatory Excellence (RCOREs) in eight different functions.

The Southern African Tuberculosis and Health Systems Support (SATBHSS) project was launched in Maputo, Mozambique in December of 2016. The project is funded by the World Bank (WB) and implemented in four (4) Southern African Development Community (SADC) countries; Zambia, Malawi, Mozambique and...

The African Union (AU) Model Law is a legislative framework that addresses these challenges by harmonizing requirements and processes. View the infographic for the processes.

The Southern African Tuberculosis and Health Systems Support (SATBHSS) project was launched in Maputo, Mozambique in December of 2016. The project is funded by the World Bank (WB) and implemented in four (4) Southern African Development Community (SADC) countries; Zambia, Malawi, Mozambique and...

Meeting Documents

Overall Goal of the Session

To mobilise political, technical and financial support from governments, the private sector and partners, so as to enable the strenthening of medical products regulatory systems and to support the growth of the pharmaceutical sector in Africa...

The purpose of this Call for Abstracts is to request potential participants in the third Biennial Scientific Conference on Medical Products Regulation in Africa to submit abstracts that respond to the overall goal, specific objectives and session objectives as presented in the conference...

The first Biennial Scientific Conference on Medicines Regulation in Africa brought together under one roof regulatory authorities, pharmaceutical industry, researchers, academia, and policy makers to share scientific advances and current best practices in regulatory science...

The overall goal of the third Biennial Scientific Conference on Medical Products Regulation in Africa is to review progress and deliberate on actions for sustaining the momentum for regulatory systems strengthening and harmonisation in Africa for addressing diseases that affect the...

The meeting sought to demonstrate the value of investing in the AMRH initiative and to identify additional donors to fund African Regional Economic Communities’ (REC) plans to expedite and strengthen medicines registration through regional harmonisation. The meeting also sought to sensitise...

The purpose of the conference was to explore the possibilities of supporting medicine the process of registration harmonization within the African Regional Economic Communities (RECs) and also to initiate a strategic approach to the development of project proposals for mobilizing the necessary...

Please register for the conference online here - http://www.nepad.org/scientificconference


The overall goal of the 3rd Biennial Scientific Conference on Medical Products Regulation in Africa is to review progress and deliberate on actions for sustaining the momentum for regulatory...

The Scientific Conference on Medicines Regulation in Africa is a biennial event that provides a platform for stakeholders to reflect on the progress in regulatory systems in Africa and map the trajectory moving forward. The inaugural 1st Biennial Scientific Conference was held in...

This meeting was the final consultation aimed at sensitizing RECs, NMRAs and the pharmaceutical industry in North/North-East Africa region on the value of harmonization and collaboration in the area of medicine regulation with a particular focus on registration. Specifically,...

The first Biennial Scientific Conference on Medicines Regulation in Africa brought together under one roof regulatory authorities, pharmaceutical industry, researchers, academia, and policy makers to share scientific advances and current best practices in regulatory science...

Newsletters

Content - Highlights

  • EAC-MRH programme Third Joint Medical Dossier Evaluation assesses 27 applications
  • NEPAD receives feedback on compiled regional AMRH M&E preliminary results report
  • SADC Medicines Regulators Forum review progress on Phase
  • ...

Content - Highlights

*  Central Africa develops 2017 Work Plan to implement Common Pharmaceutical Plan & Medicines Regulatory Harmonization Project
*  Fund for African Pharmaceutical Development (FAP-D) a gateway to financial sustainability ...

The newsletter communicates the successes of the African Medicines Regulatory Harmonization (AMRH) programme between January 2016 and June 2016, towards achieving its objective of championing medicine regulatory harmonisation in Africa. Amongst other significant milestones reported, this...

Content - Highlights

  • AU Member States review key AMA documents on the margins of the STC on Health,
  • Population and Drug Control (HPDC)
  • Joint assessments in East Africa reduce medicines regulatory review time by 40 - 60%
  • AMRH Champions
  • ...

Policy Briefs

The African Medicines Regulatory Harmonisation (AMRH) Programme facilitated the development of the African Union (AU) Model Law on Medical Products Regulation in partnership with cooperating partners. The Model Law was officially adopted by the AU Assembly in January 2016. This policy brief...

Model Law on Medical Products Regulation by AU Heads of State and government in January 2016, the next strides involve engaging with regional economic communities (RECs), regional organisations (ROs), and member states in updating and enacting regional legal frameworks and national laws. The...

The AU Model Law on Medical Products Regulation and Harmonisation in Africa aims to address legislative gaps that hamper effective medicines regulation and regional harmonisation; it will ensure a systematic approach for the development of a harmonised legislation on medicines...

The document contains abstracts from the proceedings of the1st Biennial Scientific Conference on Medicines Regulation in Africa. The compilation begins with abstracts concerning Africa’s position on the Global regulatory environment. This is followed by various topics relating to medicines...

The medical products regulation and harmonisation agenda in Africa is largely motivated by a need to increase access to essential health technologies and bolster continental innovation. An adequate health care workforce and medicines regulatory science expertise are essential factors in...

The regulation of health technologies is a critical component of every country's public health system and ensures that high-quality, safe health technologies reach the people who need them most. Unfortunately, the capacity of many low- and middle-income countries (LMICs...

Policy Report

The second Biennial Scientific Conference on Medicines Regulation in Africa reviewed progress made by Africa in strengthening regulatory systems. With a theme of Medical Products Regulatory Systems Strengthening: Promoting Research, Innovation, Manufacturing and Increased...

The purpose of the situation analysis was to establish the status of medicines regulation capacity, harmonisation efforts and challenges in SADC and member states with a view to enhancing better understanding of the situation in the region, learning from past experience and...

Strengthening Pharmaceutical Innovation in Africa is a long-term capacity building programme established by African researchers and political leaders who are involved in health research and pharmaceutical innovation. This revised report presents findings from a review of the literature (Chapter...

This report documents findings from a study of the status of medicines regulation capacities, harmonization efforts and challenges in ECOWAS and member states. Data collected from 13 out of 15 NMRAs and two pharmaceutical industries from ECOWAS is presented. The data reveals important challenges...

The main goals of Africa’s Science and Technology Consolidated Plan of Action (CPA) are to strengthen Africa’s capacities to develop, harness and apply science, technology, and innovation to achieve millennium development goals (MDGs), as well as mobilizing the continent’s expertise and...

The purpose of the situation analysis was to establish the status of medicines regulation capacity, harmonisation efforts and challenges in the EAC and member states with a view to enhancing better understanding of the situation in the region, learning from past experiences...

This Situation Analysis Report on Medicines Registration Harmonisation for the Economic Community of West African States (ECOWAS) has been prepared following rigorous scientific methods and participatory methods. Assessment instruments (AI) consisting of three separate structured questionnaires...

Press Releases

Johannesburg, December 18th, 2016 –  The Chairperson of the African Union Commission (AUC), HE Dr Nkosazana Dlamini Zuma, has made a landmark decision by appointing ten (10) eminent experts from various fields to serve on the High Level African Panel on...

Research Papers

This paper provides a comprehensive review of impact oriented methodology (IOM), which is a newly developed monitoring and evaluation tool to support the Directorate General for Research and Innovation (DG Research and Innovation) of the European Commission (EC) in their task of monitoring...

Strategic Documents

The African Medicines Regulatory Harmonization (AMRH) new strategic plan (2016 – 2020) defines the strategic direction for the medicines harmonization agenda in Africa and provides direction for advancing the development of the pharmaceutical sector. It also provides guidance in monitoring,...

Toolkits

Training Materials

This training manual has been developed for use by NEPAD designated RCOREs with clinical trials oversight and other interested institutions to deliver training programs for regulatory personnel across National Regulatory Agencies (NRAs) in Africa. It may also be used for the training of...

03 March 2017
The Zanzibar House of Representatives has successfully approved the bill amending the legislation on medical products regulation based on the African Union (AU) Model Law on medical products...
22 February 2017
The African Medicines Agency will contribute to establishing an enabling environment for the development of the pharmaceutical industry
26 May 2016
The NEPAD Agency, through its African Medicines Regulatory Harmonization (AMRH) programme has reaffirmed its commitment to continue supporting the implementation of regional Medicines Regulatory...
After the Southern and East African region, West Africa has launched its Medicines Regulatory Harmonisation Project in Accra, Ghana, today, to regulate good quality and affordable medicines in the...
After the Southern and East African regions, West Africa will launch its Medicines Registration Harmonisation Project on February 2 to 5 in Accra Ghana, to ensure rapid access to safe and effective...
Contact:

Email: nancy@nepadst.org

Back to Top