African Union Development Agency (AUDA-NEPAD) COVID19 Webinar Series on galvanising African industrial capacity to supply pharmaceuticals and medical products

Topic: Robust regulatory systems: A critical enabler of local pharmaceutical development in Africa

9th June, 2020

3pm S.A.S.T / 1pm GMT

Background

Assembly Decision {Assembly/AU/Dec.55(IV)} 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 then NEPAD.

In 2012 the 19th African Union Assembly Decision {Assembly AU/Dec.442(XIX)} on AU endorsed the PMPA Business plan which provides a package of technical and policy solutions to the challenges hampering Africa’s progress to achieve the PMPA’s objective of creating a viable pharmaceutical industry that can provide in a sustainable manner the much needed essential medical products to improve public health outcomes while creating jobs, boosting research and development across the pharmaceutical manufacturing value chain and enhancing the industrial base of the continent.

Regulatory Systems Strengthening and enforcement is a critical pillar in suite of solutions recommended in the PMPA and its associated business plan for operationalising the Pharmaceutical Manufacturing Plan for Africa.

In order for Africa to attain self-sufficiency in pharmaceutical production, improved health outcomes and increased access to essential medicines, National Medicines Regulatory Authority (NMRA)s or equivalents have a critical role to play. Africa’s NMRAs must ensure that medicines on the market are quality assured, safe and efficacious.

The specific functionalities on which the regulator in each country should focus will depend on the country’s manufacturing aspirations, level of cooperation with other NMRAs, and the regulatory body’s willingness to identify weakness in their systems that prevents them from delivering their role as a protector of public health.

Providing a robust quality system, which regulators plays a big function in, is not only a critical determinant of increase access to essential medicines and better health outcomes, but collaboration amongst NMRA’s expands markets, increases market access and subsequently offers possible economies of scale and scope. These benefits become more critical in the wake of the Covid19 pandemic making it necessary for Africa, more than ever, to look inward for solutions to curb the negative effect of the pandemic and the dependence on aid from other continents.

It is against this background that AUDA-NEPAD is organising a series of webinars, which was launched on 13th April 2020, and its aimed at galvanising African industrial capacity to produce the much-needed pharmaceuticals and medical supplies to respond to Covid19 and future pandemics.  

Speakers and Panelists

Keynote Speakers

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Mr. Joshua Setipa

Managing Director, The Technology Bank

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Dr. Emily M. Kaine

Senior Vice President, Global Health, for USP

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Dr. David Mukanga

Senior Program Officer Regulatory Affairs, Africa Systems at Bill and Melinda Gates Foundation

Panellists

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Mr. Sinhue Noronha

CEO of Africure Pharmaceuticals Limited.

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Dr William Wekwete

Head-Evaluations and Registration for Medicines Control Authority in Zimbabwe.

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Margaret-Ndomondo Sigonda

AUDA-NEPAD

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Dr. Francis Aboagye-Nyame

Director - Medicines, Technologies, and Pharmaceutical Services (MTaPS) Program.

Facilitator & Closing Remarks

Dr. Janet Byaruhanga

Senior Programme Officer, Public Health, AUDA-NEPAD

Olakunle Olaniyi-Edwards

Executive Director, DFS-Africa

Participants

The meeting will be attended by the following: AUDA-NEPAD, FAPMA and its regional TRADE associations, SAGMA, WAPMA, FEAPM, AfDB, Afrexim Bank, UNECA, USP, DFS Africa. These will be joined by a range of other invitees from the UN, NGOs, Academia, development partners and the public