‘Post-registration medicinal products monitoring in sub-Saharan Africa’: meeting report published
Today the European & Developing Countries Clinical Trials Partnership (EDCTP) published the report of the meeting on ‘Post-Registration Medicinal Products Safety Monitoring in sub-Saharan Africa’. This meeting was held in Cape Town, South Africa on 4 November 2012 as part of preparations for EDCTP2. Its aim was to discuss with other stakeholders opportunities to address issues related to safety and effectiveness of new medicinal products following regulatory approval and during deployment. Invited participants included African and European experts from the research community, the pharmaceutical industry, product development partnerships, regulatory agencies, funders as well as policymakers.
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As introduction to the topic of the meeting, Dr Alex Doodo (University of Ghana Medical School; International Society of Pharmacovigilance) gave an overview of the current drugs and vaccines pharmacovigilance activities in Africa. This was followed by a discussion of the comprehensive post-registration programme GlaxoSmithKlein (GSK) Biologicals developed for malaria vaccine RTS,S/AS. Dr Edith Roset Bahmanyar, senior epidemiologist at GSK Biologicals, hoped that in collaboration with other partners the post-approval study tools would lead to a model for the development of new sentinel centres in African countries that have no surveillance in place. These presentations were followed by discussions on a wide range of issues, such as capacity development, good governance, pregnancy registries and collection and sharing of high quality safety and product effectiveness data.
The safety of new medicinal products should be assessed during their complete life-cycle. However, pharmacovigilance in resource-limited countries is challenged by a range of complex factors. In the majority of African countries pharmacovigilance activities are either non-existent or rudimentary. With increased access to essential drugs and the roll-out of vaccines particularly intended for low- and middle-income countries, there is clearly a greater need to monitor the safety and effectiveness of medicinal products. For the second programme EDCTP – supporting the complete life-cycle approach – will seek to define its role in phase IV studies. One aspect of that role is to be a broker bringing together all pertinent partners and also to participate in the required capacity development relevant to improve post-registration safety monitoring of medicinal products in sub-Saharan Africa.
The meeting was supported by the European Union through an FP7 grant to the support action project EDCTP-Plus (FP7-304786) which encompasses the preparations for the second phase of the EDCTP programme. The European Union is not liable for any use that may be made of the information contained in the report.