INTRODUCTION

Building local capacity for vaccine production and regulation was an essential tool for pandemic preparedness and response.

Only 1% of vaccines used in Africa were produced locally.

In April 2021, the African Union (AU) launched the Partnerships for African Vaccine Manufacturing with the aim of moving away from dependency and towards health sovereignty. The African Union's (AU) goal was 60% self-sufficiency in vaccines by 2040.

Several vaccine production facilities were being planned on the continent at the time, to produce a range of vaccines including COVID-19 vaccines. The production processes of the vaccines, the facilities and products had to be controlled and approved by regulatory authorities in these countries.

Both national and regional regulatory authorities needed to be strengthened, as well as the future African Medicines Agency (AMA) and the African Medicines Regulatory Harmonisation (AMRH) Initiative.

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

A study tour of the regulatory authorities from Ghana, Rwanda, Senegal and South Africa, AMRH and representatives of EAC, ECOWAS and SADC to the German PEI took place from 9-12 May 2022, during which an initial exchange on vaccine regulation and cooperation opportunities were discussed.

A work plan was developed and the group agreed to meet regularly to exchange information and steer the implementation of the work plan. A "Letter of Cooperation" sets out the nature of the planned collaboration.

Another study tour by this group to the South African National Control Laboratory, was planned from 27th February until 1st of March 2023.

OBJECTIVES
The aim of this study tour was to exchange on lot release aspects of vaccines regulation, including risk-based approaches of lot release testing, as well as increase cooperation and mutual learning in the field of vaccine regulation.

The South African National Control Laboratory (SANCL) embedded in the South African Health Products Regulatory Authority (SAHPRA) shared information on their risk-based approach for lot release testing and their respective guideline.

The German PEI shared information on the German and European regulatory system and procedures for vaccines lot release while the African regulators presented their current systems and strategies for lot release.

The African Medicines Quality Forum under the AMRH Initiative shared information on their strategy on harmonization of lot release on the African continent.

A laboratory tour through SANCL was planned for the last day.

PARTICIPANTS
It was planned to invite three participants from each of the respective regulatory authorities: the heads of the regulatory authorities (Ghana FDA, Rwanda FDA, Senegal ARP, SAHPRA) and two technical staff involved in lot release and testing, in total 12 participants.

Three representatives from Paul-Ehrlich- Institut (PEI).

Representatives from GIZ Ghana, Senegal and South Africa

Three participants from the African Medicines Regulatory Harmonisation (AMRH)

Initiative / African Medicines Quality Forum (AMQF).

It was planned to invite one representative from Egypt (as African vaccine producing country) and Nigeria (chair of AMQF vaccine subcommittee).

LOGISTICS
Timeline: 27th February until 1st of March 2023, on-site meeting at SANCL, South Africa.

Laboratory visits at SANCL.

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