200 experts. 900 days. The twinning project pairs Rwanda Food and Drug Authority (RFDA) with Team Europe actors to develop an enabling regulatory environment for vaccines and health products in Rwanda.
Initiated by the EU Delegation to Rwanda, this twinning project has proven to be a groundbreaking and successful partnership. The project, grounded in available evidence of what works in capacity building, benefits all parties involved and has inspired other countries.
It also marks the first collaboration of this kind between Rwanda and European public authorities, the first twinning in the health sector in Sub-Saharan Africa, and the first partnership of this nature that involves so many EU Member States. It’s a real Team Europe endeavour, implemented by France in partnership with Germany, Belgium, and Lithuania, and further expertise has been mobilised from Greece, Sweden, and Austria, ensuring the needs of the partner remain front and center.
This project is part of the Team Europe Initiative on Manufacturing and Access to Vaccines, Medicines and Health Technologies in Africa.
Objectives
This twinning project initially focused on:
- improving legal framework and regulatory functions linked to health products;
- strengthening market surveillance, focusing on vigilance and laboratory testing functions; and
- supporting the establishment of batch release function for vaccines.
As the project progressed, an additional goal emerged:
- supporting RFDA in achieving Maturity Level 3 in the World Health Organization (WHO) benchmarking tool.
The WHO Global Benchmarking Tool aims to evaluate the overarching regulatory framework and its component regulatory functions. This tool rates regulatory systems on a scale of 1 (few elements of regulatory system existing) to 4 (advanced level of regulatory system) to assess the overall maturity of the regulatory system.
Achieving this third level for Rwanda would confirm that a stable, well-functioning and integrated regulatory system is in place.
Project activities
- Developing and implementing diverse trainings for the staff members
- Supporting and revising overall legal framework, including on batch release and pharmacovigilance system for MAHs
- Developing quality management system and crisis and risk management system plan
- Developing the qualification process for inspectors
- Enhancing Rwanda's capacity to develop regional cooperation
- Creating an action plan to improve the RFDA laboratories
- Initiating benchmarking of lot release related functions
Results
- Key accomplishment related to surveillance
- Developing a pharmacovigilance training plan
- Updating 4 guidelines related to the regulatory framework for clinical trial oversight
- Staff members who participated in trainings improved their ability to analyse safety reports in the pharmacovigilance system
- Highlights related to establishing lot release for vaccines
- Developing a legal framework for batch release
- Creating Standard Operating Procedure to perform the batch release
- Developing and delivering trainings for RFDA, which have already been completed by half of the relevant staff members
- Additional accomplishments
- Staff members who participated in training improved their skills in some regulation functions, including marketing authorisation
- Four Rwanda FDA inspectors have been trained to improve their skills in Good Clinical Practice (GCP), Good Distribution Practice (GDP) and Good Manufacturing Practice (GMP) inspections
- Developing an action plan to improve RFDA laboratories
Lessons from the field
If you learn new information on the ground and a clear priority comes into focus, adapt the plan!
Depending on your twinning project, your teams might be far apart geographically. Ensure your teams are making time for virtual and in-person meetings and look for opportunities to keep motivation high.
New medicines regulatory agencies have their work cut out for them. Partnering intensively with experienced agencies can enable them to gain expertise and align with international regulations, which in turn can accelerate their ability to provide for and protect the people they serve.