A decade of the AMRH initiative

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The 55th Decision of the African Union (AU) taken during the Abuja Summit in January 2005 requested the AU Commission to develop a Pharmaceutical Manufacturing Plan for Africa (PMPA) within the framework of the New Partnership for Africa’s Development (NEPAD), now known as African Union Development Agency-NEPAD. The PMPA is aimed to improve access to good quality, safe and efficacious medical products and health technologies for the African population.

The African Medicines Regulatory Harmonization (AMRH) initiative started in 2009 to address the fragmented regulatory systems on the African continent and provide an optimal environment for local production of medical products and health technologies on the continent. For over a decade now the continent has witnessed significant progress in harmonisation of technical requirements for registration of medical products and good manufacturing practice (GMP) guidelines through the AMRH initiative working with regional economic communities (RECs) and national medicines regulatory agencies (NMRAs). The initiative has also focused on implementation of quality management systems and information management systems to respectively improve quality of services and sharing of information among stakeholders.

Consequently, countries have been able to conduct joint reviews of dossier applications and inspection of manufacturing sites, with subsequent reduction of timelines for marketing approval to a median of seven to eight months, as reported in the East African Community and the Southern African Development Community (SADC) regions.

In addition, implementation of quality management systems by NMRAs through RECs MRH Projects have resulted in attainment of International Standards Organization (ISO) standard by a significant number of NMRAs. For instance, four out of seven NMRAs in the EAC, namely Kenya Pharmacy and Poisons Board (K-PPB), Tanzania Medicines and Medical Devices Authority (TMDA), Zanzibar Food and Drug Authority (ZFDA), and the National Drug Authority of Uganda (NDA) are 9001:2015 ISO-certified.

In the Economic Community of West African States (ECOWAS); five NMRAs have attained ISO 9001:2015 certification under the MRH Project namely, the Food and Drug Authority of Ghana (FDA Ghana), the National Agency for Food and Drug Administration and Control (NAFDAC) Nigeria, Liberia medicines and Health Products Regulatory Authority (LMHRA), Pharmacy Board of Sierra Leone, and Medicines Control Authority (MCA) of The Gambia. Meeting the requirements for ISO certification provides a guarantee that ensures that its regulatory processes are conducted in a uniform and rigorous manner.

To address weaknesses in national medicines laws, 17 AU Member States have domesticated the model law on medical products regulation, with a subsequent increase in the number of autonomous NMRAs. In the EAC region, five out of seven NMRAs (71.4%) are semi-autonomous, namely KPPB, Rwanda Food and Drug Authority (RFDA), South Sudan Food and Drug Authority (SSFDA), TMDA, ZFDA and NDA. In the ECOWAS region, 10 out of 15 countries (66.6%) have autonomous agencies that provide guarantee in the co-ordination and financing of regulatory activities in a country. They are Benin, Burkina Faso, Cabo Verde, Cote d’Ivoire, The Gambia, Ghana, Guiné-Bissau, Liberia, Nigeria and Sierra Leone.

These noted results through implementation of the AMRH initiative are key in building robust regulatory systems in Africa, including the establishment of the African Medicines Agency (AMA). Key success factors also include the harmonisation of technical requirements and joint regulatory activities conducted by NMRAs, coupled with sound governance systems such as Expert Working Groups and Steering Committees oversights. — Margareth Ndomondo-Sigonda, AUDA-NEPAD Head of Health

“The African Medicines Regulatory Harmonization  (AMRH) Initiative is key in building robust regulatory systems in Africa” says @Nepad_Agency Head of Health Margareth Ndomondo-Sigonda. #TheAfricaWeWant