Efficiency and Transparency in Drug Authorisation through Regulatory Structures: Workshop with the Medicines Control Agency (MCA) in The Gambia
April 2025
Looking Back on Seven Years of Successful Partnership
In April 2025, the GHPP PharmTrain2 project team visited its long-standing partner institution, the Medicines Control Agency (MCA) in The Gambia. The two-day working meeting served to assess the current status of regulatory structures in the area of marketing authorisation, reflect on the progress and define further steps for strengthening the agency. Aside from the technical partners, also senior management from MCA, a representative of the World Health Organization (WHO), and the chair of the Technical Working Group on Marketing Authorisation (TWG-MAG) from Ghana.
Reaching Milestones Together
During the workshop, the MCA presented impressive progress and the ongoing development of its regulatory structures, achieved in close collaboration with PharmTrain2. The Chair of the TWG-MAG and MCA staff provided practical insights into their experiences building regulatory frameworks and demonstrated how these structures are becoming increasingly integrated into daily operations. Challenges - such as the implementation of standard operating procedures and guidelines, were addressed openly. A particular highlight of the workshop was a full-day “Self-Benchmarking” exercise in the area of marketing authorization (MA): Applying the WHO Global Benchmarking Tool, participants evaluated developments since their last data collection in 2021. The exercise clearly showed substantial structural progress by the MCA. At the same time, specific areas for further development were identified—particularly regarding documentation and the routine application of internal procedures—providing a sound, objective basis for continued collaboration.
Looking Ahead
During a joint planning session, the MCA reaffirmed its strong commitment to further expanding the regulatory structures and competencies needed to strengthen the agency. Key technical priorities were identified, including the evaluation of pharmaceutical quality and clinical assessments. A concrete work plan for 2025 was agreed on.
The MCA also expressed strong interest in continuing the collaboration beyond the current year.
A Reliable Partnership
This visit once again highlighted the constructive, trustworthy, and forward-looking partnership with the MCA Gambia. The clear interest of the senior management and technical staff in continuing the development of regulatory structures, makes the institution a reliable partner. The PharmTrain2 project looks forward to continuing this successful collaboration and achieving further milestones together with the MCA Gambia supporting the sustainable development of a strong regulatory system.