Dakar – The NEPAD Agency, through its African Medicines Regulatory Harmonization (AMRH) programme has reaffirmed its commitment to continue supporting the implementation of regional Medicines Regulatory Harmonization (MRH) projects in line with its vision of ensuring that African people have access to essential medical products and technologies.

This was revealed by AMRH Programme Coordinator, Margareth Ndomondo-Sigonda in Dakar, Senegal during the two (2) day AMRH Advisory Committee meeting Chaired by the African Union Commission (AUC). The meeting was attended by regional economic communities (RECs) and regional organization (ROs) namely; the East African Community (EAC); the Southern African Development Community (SADC);  the Economic Community of West African States (ECOWAS); the West Africa Economic and Monetary Union (WAEMU); the Intergovernmental Development Authority (IGAD); the Organization for the Coordination and Control of Endemic Diseases in Central Africa (OCEAC); and the Common Market for Eastern and Southern Africa (COMESA). 

In addition, representatives from cooperating partners namely World Health Organization (WHO); World Bank; the Federation of African Pharmaceutical Manufacturers Association (FAPMA); the Pan African Harmonization Working Party (PAHWP); and the International Federation of Pharmaceutical Manufacturers Association (IFPMA) also participated as members of the AMRH Advisory Committee.

The role of the AMRH Advisory Committee is to provide advice on strategy and policy in the implementation of the AMRH Programme. This includes the development and implementation of sustainable financing and regulatory capacity building programmes; promotion of establishment of regional centres of regulatory excellence; and advice on AMRH advocacy and communication.

“The NEPAD Agency role in the coordination of RECs and partners; and alignment of national, regional and continental regulatory interventions is critical in realizing the medical products regulatory harmonization agenda in Africa,” said Mrs. Sigonda.

The meeting reviewed progress being made in the various RECs in the implementation of MRH progress which also served as a platform for sharing experience and learning among RECs. Practical approaches of joint assessments of medical products among countries in the EAC and SADC regional were discussed and consensus reached on standardising regulatory approaches used by various regions based on agreed best practice. The aim is to put in place regulatory mechanisms that are effective, efficient and transparent for faster approval and subsequent availability of the products in various African markets. For example, through pilots and joint assessments, the EAC partner states have approved a total of 13 products since 2011 while the SADC region has approved 28 products under the ZAZIBONA approach that was initiated by Zambia, Zimbabwe, Botswana and Namibia since 2013.

The NEPAD Agency and partners were urged to facilitate coherence across RECs by developing standardised frameworks for implementation of various streams of harmonization including advocacy on utilization of AMRH Implementation Toolkit.

Source: NEPAD