BACKGROUND

Almost two years after the outbreak of the COVID 19 pandemic, only about 6% of the population in Africa was fully vaccinated. In comparison, over 70% of high-income countries had already vaccinated more than 40% of their people.

The difficulties in accessing sufficient vaccine supplies were a wake-up call for Africa to increase local vaccine production in the medium to long term.

In April 2021, the African Union (AU) launched the African Vaccine Manufacturing Partnership with the aim of moving away from dependency and towards health sovereignty. In addition to strengthening pharmaceutical production, there was an urgent need to support pharmaceutical regulation in Africa. A stringent registration process, quality control of health products, continuous market surveillance and pharmacovigilance are required to ensure access to safe, effective and quality assured locally produced products. Both national and regional regulatory authorities need to be strengthened, as well as the future African Medicines Agency (AMA) and the Africa Medicines Regulatory Harmonisation Initiative (AMRH). Today, no regulatory authority can work in isolation - without regulatory cooperation and harmonisation of pharmaceutical regulations, access to medicines and vaccines cannot be ensured.

The German Development Cooperation with its implementing organisations the German national metrology institute PTB and GIZ, worked closely with the Paul Ehrlich Institute (PEI) to support African regulatory authorities, especially in the field of vaccine regulation.

THE STUDY TOUR & WORKSHOP

In May 2022, PTB and PEI organised a study tour to PEI in Langen, Germany for the regulatory authorities from Ghana, Rwanda, Senegal and South Africa, AMRH and representatives of EAC, ECOWAS and SADC, during which an initial exchange on vaccine regulation and cooperation opportunities was discussed. An additional site meeting at the German Federal Ministry for Economic Cooperation and Development (BMZ) in Bonn, Germany was organised.

AGENDA

9 - 12 May 2022: on-site meeting at Paul-Ehrlich- Institute (PEI), Langen, Germany including laboratory visits at PEI

13 May 2022: on-site meeting at German Federal Ministry for Economic Cooperation and Development (BMZ), Bonn, Germany

OBJECTIVE
The aim was to establish a network between vaccine regulatory authorities from Germany, Ghana, Rwanda, Senegal and South Africa, improve the understanding of the respective vaccine regulatory systems, as well as increase cooperation and mutual learning in the field of vaccine regulation.

The German PEI shared information on the German and European regulatory system for vaccines while the African regulators presented their current systems in vaccine regulation and need for upgrade. The objective was to:

• Exchange expertise, discuss challenges and best practices.
• Improved knowledge in technical session on the topics of
• lot release systems for vaccines and
• GMP inspection procedures and licencing of vaccine manufacturers.

A workplan on further joint activities (e.g. trainings, technical advice, further study trips) was developed.

PARTICIPANTS

In total, 18 participants from Ghana FDA, Rwanda FDA, Senegal FDA, SAPHRA, from the African Medicines Regulatory Harmonisation (AMRH) initiative, representatives from the RECs EAC, ECOWAS and SADC, and technical staff participated in the workshop.

SPONSORSHIP & FUNDING

The event was organised and funded by PTB and PEI.

PTB CONTACT

Anna Reinhardt, Project Coordinator, anna.reinhardt@ptb.de

Lisa Köhler, Project Assistant, lisa.koehler@ptb.de