AMRH Partnership Platform – a game changer in the medicines regulatory space

Submitted by hlazom on Fri, 08/03/2018 - 14:12
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Many international and local partners and stakeholders working in the medicines regulatory systems strengthening and harmonization space in Africa have for a long time worked in silos and lacked coordination especially at the continental level. Technical capacity and human resources end up being spread thinly, impact is limited with no proper mechanism to promote exchange of information and learning. As a result, sustainability of these parallel interventions is now a challenge and it has become difficult to take stock on who is doing what, where are they focusing their work, who are they targeting and what their interests are in Africa.

These pertinent questions are now a subject of critical reflection if we are to attain the common agenda of improving access to safe, efficacious and good quality essential medicines in Africa. This obviously common shared vision is threatened by the lack of coordination in this stream of work in Africa. Hence, NEPAD Agency in collaboration with the World Health Organization (WHO) and other partners have agreed on establishing a coordination mechanism that will not only oversee medicines regulatory systems strengthening and harmonization work in Africa but also coordinate various partners by establishing a single platform. This platform is vital in efforts aimed towards avoiding duplication of work, ensure optimal utilization of resources and establish consensus on priority areas of intervention.

The African Medicines Regulatory Harmonization (AMRH) Partnership Platform is the answer to ensuring that there is effective coordination and management of different partners and stakeholders in the medicines regulatory systems strengthening and harmonization space in Africa. The AMRH PP will be established as an African chapter of the global WHO Coalition of Interested Parties (WHO-CIP). The AMRH-PP shall serve African interests and priorities in the medicines regulatory space in alignment with global WHO priorities. The AMRH-PP shall provide coordination and direction to partners and stakeholders working in Africa in addressing the many challenges in the continent’s public health sector.

The AMRH-PP comes at the right time when AMRH and African Vaccines Regulatory Forum (AVAREF) have agreed in principle to harmonize and align the initiatives. The AMRH-PP will leverage harmonization and alignment of AMRH and AVAREF in Africa to build on the proven operating model of working through the National Medicines Regulatory Authorities (NMRAs) and Ethics Committees (ECs), Regional Economic Communities (RECs) and Regional Health Organisations (RHOs), and the African Union Commission (AUC) to address gaps in regulatory capacity at national, regional and continental levels.

A call for Expression of Interest (EOI) to join the AMRH-PP was circulated to all partners and stakeholders in early February 2018 with a deadline to submit by 15th March 2018. Over 50 applications have been received from various partners and stakeholders expression interest to join the AMRH-PP. The First AMRH-PP meeting of existing partners will be held in Johannesburg, South Africa on 11th April 2018. It is at this meeting that the EOIs received will be reviewed and recommendations will be sent to the AMRH Steering Committee (SC) for endorsement. Thereafter, all the AMRH-PP members in Africa will map out a common agenda with clear roles and responsibilities for each one.