The vision of AMRH is to ensure that African people have access to essential medical products and technologies that promote public health

The African Medicines Regulatory Harmonisation (AMRH) Programme aims to contribute to the broader AUDA-NEPAD and AU vision and mission. Of particular focus to AMRH is the African Union Pharmaceutical Manufacturing Plan for Africa (PMPA) endorsed by AU Heads of State in 2005 and the Roadmap for Shared Responsibility and Global Solidarity for the AIDS, TB and Malaria response in Africa, endorsed by AU Heads of State in 2012. Both decisions focus on ensuring the sustainable supply of quality essential medicines to improve public health and promote industrial and economic development on the continent.

The AMRH works on the premise that the regulatory agencies of the African Union’s 55 member states currently operate independently with limited capacity, different regulatory requirements that have invariably resulted in the circulation of substandard and falsified medicines in most African markets. In addition, the different regulatory environment in each country is a technical barrier to pharmaceutical trade between countries and across regions in Africa.

The rationale for designating Regional Centres of Regulatory Excellence (RCOREs) is informed by the reality of medicines regulatory capacity limitations that continue to hamper access to essential medicines and occasion limited progress in regulatory harmonisation efforts in Africa. The need for regulatory capacity

upgrade in African National Medicines Regulatory Authorities (NMRAs) is crucial to ensure the effective regulation of products in African markets. Regulatory capacity is equally essential for NMRAs to build accurate risk-benefit profiles in assessing product dossiers for marketing authorisation in the African context.

Despite much discussion and lamentation about regulatory capacity limitations in Africa, few deliberate and systematic efforts have been made to address these. Most training programmes offered thus far have largely been presented on an ad-hoc basis, been reliant on external financing and have hardly been formally adopted into the programmes of existing institutions such as NMRAs and local academic institutions. The establishment of RCOREs is intended to fill this regulatory gap and ensure the sustainability of regulatory training programmes.

Among the challenges that continue to confront regulators are the increasing complexity of regulatory work – as a result of new technologies, globalisation of commercial activities and new product development processes. Most African countries lack the medicines regulatory capacity to address these challenges. Furthermore, in different countries, different institutional arrangements for the regulation of medicines hamper efforts for medicines regulatory harmonisation. There are vast differences in expertise and knowledge in the different NMRAs and countries. A situation analysis study commissioned by NEPAD Agency during 2010 demonstrated that only a few African countries meet all the criteria for NMRA functionality including the existence of a functional administrative NMRA, a legal framework for NMRAs, the performance of full regulatory functions and the availability of suitable and qualified human resources.

The NEPAD Agency launched the RCOREs Programme in 2012 through a series of extensive and inclusive consultations with all key stakeholders and experts. This culminated in the publication of a call for expressions of interest, in October 2013, from institutions wishing to be selected as RCOREs and a selection process that designated 10 RCOREs in May 2014. 1 further institution which had been provisionally designated in 2014 was fully designated in 2015. It is also important to note that the work of RCOREs contributes and feeds into the Science, Technology and Innovation Strategy for Africa (STISA) 2024 and the Second Decade of Education for Africa (2006-2015) Plan of Action which are key AU pillars in science, technology, innovation and human capacity development. Increasing human and institutional capacity for the regulation of medical products and technologies will also contribute to the realisation of two key AU frameworks, namely the Pharmaceutical Manufacturing Plan for Africa (PMPA) and the Roadmap on Shared Responsibility and Global Solidarity for AIDS, TB and Malaria Response in Africa. The two latter frameworks propose a suite of high priority actions to ensure accelerated access to affordable and quality-assured medicines and health-related commodities. These priority actions include the acceleration and strengthening of regional medicines regulatory harmonisation initiatives for which RCOREs will make an immense contribution.

RCOREs have been categorised according to their areas of expertise and strength in training and / or service delivery in at least one of the following regulatory functions:

1. Assessing the safety, efficacy and quality of medicines, and issuing marketing authorisation;

2. Clinical trials oversight;

3. Licensing of the manufacture, import, export, distribution, promotion and advertising of medicines;

4. Pharmacovigilance and Pharmacoepidemiology;

5. Inspection and surveillance of manufacturers, importers, wholesalers and dispensers of medicines;

6. Providing independent information on medicines to professionals and the public; and

7. Quality Assurance and Quality Control of medicines and medical devices.

In addition, institutions providing training in the following areas could be considered for designation as RCOREs: medicines laws and policies, Regulatory Systems, NMRA Quality Management Systems (QMS) and Regulatory Information Management Systems (IMS), Good Regulatory Practices (GRPs), Regulatory Performance Monitoring, Pharmacoeconomics and Health Technology Assessment (HTA) and medicines pricing regulation.

a) Identify and prioritize the main regulatory functions that need capacity building

b) Identify and prioritize the main skills required to support the regulatory functions

c) Recommend comprehensive training programs and other existing resources to support the capacity building of human resources

d) Advice on the institutionalization of training programmes for regulatory human resources

e) Identify and recommend standards and tools to promote good regulatory practices

f) Stimulate and support scientific research in regulatory sciences in Africa and beyond

National Medicines Regulatory Authorities (NMRAs) and Ethics Committees (ECs), Regional Economic Communities (RECs) and Regional Health Organisations (RHOs), and the AUDA-NEPAD, African Union Commission (AUC), Pan African Parliament (PAP), WHO, BMGF, Clinton Health Access Initiative (CHAI), World Bank, Foreign, Commonwealth & Development Office (FCDO)- formerly UK Department for International Development (DFID), Federation of Pharmaceutical Manufacturers Association (FAPMA)