West Africa: TWG-MAG - Joint Technical Working Group for Guideline Development in Marketing Authorization

Aim: In a unique process for West Africa, four partner authorities are working together with the BfArM GHPP PharmTrain team for developing harmonised guidelines for marketing authorisation to strengthen the structure of their authorities.

Partner authorities: FDA (Ghana), MCA (The Gambia), LMHRA (Liberia) and PBSL (Sierra Leone)

Number of people: 8 (2 representatives per authority)

Duration:

January 2019 - December 2022 (RegTrain-PharmTrain project)
January 2023 – December 2025 (PharmTrain2 project)

Format: In monthly virtual meetings and annual workshops in Ghana and in Germany at the BfArM facilitated by the PharmTrain team, experts from the four partner authorities closely collaborate to develop guidelines that are urgently needed for efficient and stable medicinal product regulation according to the WHO Global Benchmarking Tool. Existing regional, national, and international guidelines are reviewed and the working group decides whether these are fully or partially applicable for their countries, before any guideline is newly developed.

Highlights:

2019-2022 and 2023:

• TWG-MAG developed a Guideline on Guidelines as the basis for all guidelines in order to standardise the development processes and document structure. 14 regulatory guidelines and an overarching list of definitions were jointly developed and are available for download PharmTrain guideline database
• March 2023: GHPP PharmTrain2-Workshop - Joint Guideline Development for West Africa and beyond