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)

These main focus areas contribute to the African Union’s (AU) key strategic documents which include: (1) Pharmaceutical Manufacturing Plan for Africa (PMPA) (2) Road Map on Shared Responsibility on Global Solidarity on HIV/AIDS, Tuberculosis and Malaria Response in Africa (3) Health Research Strategy for Africa (4) and the Africa Health Strategy (under review).

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.

Since the programme inception in 2009, major milestones have been achieved. These achievements are documented and can be accessed and downloaded from various reports and publications in the knowledge section. Some of the main achievements to date are highlighted below:

African Union (AU) Model Law

The NEPAD Agency, through the AMRH programme, facilitated the development of the AU Model Law on Medical Products Regulation. The AU Model Law was endorsed by African Heads of State and Government at the January 2016 AU Summit in Addis Ababa, Ethiopia. The AU Model Law contributes towards harmonizing medicines regulatory systems and providing an enabling environment for the development and scale-up of health technologies in Africa.

The AU Model Law was developed in line with WHO recommendations and international safety and quality standards. It assists AU Member States in overcoming the medicines regulatory challenges that have long plagued the African continent. All AU Member States are encouraged to implement the AU Model Law and ensure alignment with its Constitutional principles and legal systems. A target of 20 countries and 5 RECs are expected to adopt the AU Model Law by end of 2018.

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.

SADC MRH Programme and ZAZIBONA Initiative

In 2015, the SADC region became the recent addition to the Medicines Regulatory Harmonization (MRH) project. Following the development of the MRH Project proposal in 2011, breakthrough activities were agreed and supported which led to the development of the Southern Africa Regional Programme on Access to Medicines and Diagnostics (SARPAM).

Following a successful Zambia, Zimbabwe, Botswana and Namibia (ZAZIBONA) Assessors meetings in 2015, a total of 103 products were reviewed. As a result, the ZAZIBONA Heads of Agencies (HoA) recommended a total of 28 products for registration within SADC Member States and the countries have already registered some of these products. The ZAZIBONA scheme is part of the SADC Framework for Regulatory Harmonization and was endorsed by the SADC Regulators Forum. More ZAZIBONA Assessors meetings will be held in 2016.

IGAD MRH Programme

In 2015, Intergovernmental Authority on Development (IGAD) Member States made a commitment by signing the Call for Action to initiate the establishment and implementation of an MRH programme in the ECCAS and OCEAC region. This Call for Action further stipulates the support for the development of an overarching regional pharmaceutical policy and the adoption of modern legislative frameworks based on the AU Model Law.

ECCAS/OCEAC MRH Programme

The collaboration framework for implementation of MRH Project in Central African region has been under discussion since 2015. The MRH programme implementation in the region will take advantage of the ongoing developments in the region including endorsement and subsequent implementation of the regional pharmaceutical policy by the Central African Economic and Monetary Union (CEMAC) Policy Organs, covering six (6) countries in the region. An assessment of regulatory systems will be conducted in 2016 to determine gaps and identify areas that need intervention under the AMRH Programme.

Designated RCoREs and Regulatory Pool of Experts Database

In 2014, the NEPAD Agency spearheaded the designation of eleven (11) Regional Centres of Regulatory Excellence (RCoREs). In order to ensure sustainability, the RCoREs are established within the existing academic, research and regulatory institutions. A comprehensive database of regulatory pool of experts has also been developed as a resource reservoir.

Strengthening Pharmaceutical Innovation in Africa

In partnership with COHRED and George Institute, NEPAD Agency played a key role in the development and publication of the “Strengthening Pharmaceutical Innovation in Africa” Report designed to support AU Member States on Pharmaceutical Innovation in Africa.

EAC MRH Programme

In 2012, the East African Community Medicines Regulatory Harmonization (MRH) programme was successfully launched and is under implementation. EAC was the first to develop harmonized technical guidelines with subsequent adoption by the EAC Council of Ministers in 2014. As a result, a compendia was published for use by all the EAC Partner States. The AMRH Monitoring and Evaluation (M&E) Framework has also been piloted among EAC Member States. The analysis is currently underway and results will be ready soon.

Expanded ToRs of the PMPA Technical Committee

The NEPAD Agency facilitated the review and subsequent expansion and endorsement of the ToRs for the PMPA Technical Committee. The ToRs were endorsed by the African Union Conference of Ministers of Health (CAMH-5) in Windhoek, Namibia in 2011. This initiative led to the development of the PMPA Business Plan with support from the United National Industrial Development Organization (UNIDO).