Continental platform approach to improve coordination of medicines regulatory work

Submitted by hlazom on Thu, 08/02/2018 - 15:37
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There is a lot of work being implemented in medicines regulatory systems strengthening in Africa. According to Dr Mike Ward, World Health Organization (WHO) Coordinator for Regulatory Systems Strengthening (RSS), one of the biggest challenges of this work has been the lack of coordination of different partners and stakeholders. He was speaking during the first African Medicines Regulatory Harmonization Partnership Platform (AMRH-PP) meeting which took place in Johannesburg, South Africa on 11 April 2018.

“The proposed establishment of this AMRH Partnership Platform is a milestone on medicines regulatory systems strengthening and harmonization in Africa”, Dr Ward said.

Dr Ward said that the only way to succeed in this work is if we take a coordinated approach. WHO is already implementing the global Coalition of Interested Parties (CIP) and there are lessons that the African chapter of the WHO-CIP can learn, as well as best practices and vice versa. He further pointed participants to the fact that since the AMRH-PP is the Africa chapter of the WHO-CIP, it must align with the global platform’s principles, values and concepts and the various partners and stakeholders must be agreeable to these aspects.

Dr Andreas Seiter, Global Lead for Private Sector in Health at the World Bank (WB) indicated that this kind of broader partnership approach is a model of how business is done nowadays and it should occur more naturally in modern times.

“No single institution or organization can call the shots and make all the decisions regarding the work on medicines regulatory systems strengthening in Africa’, Said Dr Seiter.

Dr David Mukanga said that the Bill and Melinda Gates Foundation (BMGF) strongly supports the WHO-CIP concept which allows recipients of regulatory systems strengthening support to come together around shared goals and ideas, plan together, draw lessons from each other, leverage each other’s strengths, execute together, as well as jointly promote continental convergence of systems and processes to truly realize the idea of harmonization.

“The extension of the WHO-CIP principles to the Africa region through the AMRH-PP is timely as the work expands and the foundation is fully supportive of this idea”, Dr Mukanga said.

He also stated that as this journey of continental coordination of partners and stakeholders is beginning through the AMRH-PP, this is also the right time to develop clear goals and targets bearing in mind the priorities at regional and country level, so that the work of the AMRH-PP can easily be measured at the end of the year to see how it is performing.

Head of Health Programs at the NEPAD Agency, Margareth Ndomondo-Sigonda indicated that there is a lot of interest from the African Union (AU) leadership to see AMRH advance and eventually transition in to the African Medicines Agency (AMA). Challenges of duplication of efforts in medicines regulatory systems strengthening and harmonization in Africa exist and these will be dealt with through effective coordination of this work through the AMRH-PP.

“NEPAD Agency’s role is to facilitate effective coordination of this platform in alignment with AU policies and WHO internationally accepted standards and practices’, Mrs Sigonda said.

During the meeting, it was announced that a total of 53 applications were received from different organizations and institutions expressing interest to join the AMRH-PP following the publicized call for Expression of Interest (EOI). The deadline for receiving applications was 15 March 2018. The method for for reviewing the received applications was through the use of inclusion and exclusion criteria to determine suitable members of the AMRH-PP. As a result, from the received 53 applications, 25 were accepted as members and 28 were not accepted. The applicants will soon be officially notified of this outcome.

At the first AMRH-PP meeting, the participants jointly developed a document with clear points to be presented to the Steering Committee (SC) on Regulatory Systems Strengthening and Harmonization Initiatives in Africa meeting for possible endorsement. Existing AMRH partners will not need to apply to become members of the AMRH-PP as these will automatically be part of the platform. It was also announced that three (3) members of the AMRH-PP will represent the platform in the Steering Committee (SC) meetings.