The convening of the fifth Scientific Conference on Medical Products Regulation in Africa (SCoMRA V) and the seventh African Medicines Regulators Conference (AMRC VII) could not have come at a better time as the African continent is addressing medical products supply chain disruptions caused by the COVID-19 pandemic. The discussions that emanated from the two meetings will contribute to the implementation of the African Union policy and strategic frameworks aimed at facilitating and accelerating access to medical products. The SCoMRA and AMRC serve as useful platforms for knowledge exchange and information sharing among the various stakeholders.
Key areas identified include:
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There is a need for strengthened collaborations among the various stakeholders, including researchers, academia, manufacturers, regulators, and civil society across and beyond the continent, to advance product development for diseases that affect Africa disproportionately.
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Africa has begun to manufacture and export vaccines to other countries. The receiving countries need to ensure that they can trust the regulators and countries in which the vaccines are manufactured. Attainment of WHO Maturity Level 3 (WHO- ML3), particularly by NRAs of vaccine manufacturing countries, is a priority to support continental efforts to locally produce 60% of vaccines needed on the continent by 2040.
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Regulators across Africa need to transform their regulatory practice through reliance on one another’s regulatory assessments and regulatory reports to improve efficiencies of regulatory review processes.
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There is a need to build regulatory infrastructure and capacity along the regulatory ecosystem from research and development, laboratory testing, lot release and post market surveillance. This needs to be coupled with a stringent product lifecycle management practice.
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Governments need to strengthen regulatory authorities to be able to set up efficient systems that are certified by the World Health Organisation (WHO), so as to ensure good quality vaccines. Support from reference agencies is critical as these have an important role to play in certain phases of the trials.
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Monitoring and evaluation of performance within NRAs, REC MRH efforts, Technical Committees and Regional Centres of Regulatory Excellence (RCOREs) is essential for sustaining improvements in results.
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Digitalisation is essential to support the ability to share real-time data and reporting of adverse events, as well as increasing regulatory efficiencies throughout the product life cycle.
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Capacity strengthening is still needed across the NRA workforce, drawing on the RCOREs. Some learning opportunities have emerged from the pandemic, which can be continued, particularly through online and virtual working.
Deliberations and lessons learnt from the discussions will help shape the regulatory landscape in Africa during and post- COVID-19. On behalf of the SCoMRA V and AMRC VII Organizing Committee, we take this opportunity to thank all participants for taking time to present and contribute to the discussion, which promoted knowledge sharing to facilitate the documentation of good practice. We look forward to seeing you again in 2023.
