March 2023, Bonn, Germany

The GHPP PharmTrain team kicked-off its new project phase for regulatory structure development.

For the first time in Bonn, seven representatives of the partner regulatory authorities of Ghana (FDA), Liberia (LMHRA), Sierra Leone (PBSL), and The Gambia (MCA) met the GHPP PharmTrain team for a five-day workshop at the Federal Institute for Drugs and Medical Devices (BfArM). All participants are members of the Technical Working Group for Joint Guideline Development in Marketing Authorization (TWG-MAG) (more in Structure Development). The TWG-MAG was established in 2020 and its collaboration has ever since taken place in regular virtual meetings and in two workshops in Ghana. The aim of this face-to-face workshop was to build on the working group’s success achieved so far, accelerating the development of further harmonized guidelines in marketing authorization, and kicking-off the new project phase with more plans for future structure building in the West-African region.

Discussions were stimulated by two guest presentations by Dr. Steve Estêvão Cordeiro as to how WHO establishes Norms and Standards for Pharmaceuticals and which challenges they face in developing and implementing guidelines. BfArM experts shared insights into how consistency across guidelines is ensured in the European Union and what Standard Operating Procedures (SOPs) look like at BfArM.With this knowledge at hand, the TWG-MAG engaged intensively in the onward joint development of structural documents for their authorities. They appreciated the straightforward interaction, exchange of experience, and international networking within the TWG-MAG and also with the international experts.

In a nutshell, apart from an agreed workplan for 2023, the TWG-MAG finalized three more guidelines required for advancing to a stable, well-functioning regulatory system in the area of marketing authorization. Moreover, drafting of a total of six guidelines on quality, efficacy and safety together with a core SOP marked the beginning of the new phase of this fruitful multilateral collaboration.

The harmonized guidance documents developed by the TWG-MAG before, during, and after the workshop are published in the PharmTrain Guideline Database. These documents can be used by any national medicines regulatory authority, thus strengthening the regulatory landscape and fostering structural harmonization on the African continent and beyond.