Rwanda and the European Union (EU) have launched a twinning project to strengthen the Rwanda Food and Drugs Authority in its regulatory functions related to medicinal products including vaccine manufacturing standards.
The EU-Twinning project, launched this May 16, 2023 aims to strengthen the Rwanda FDA and therefore to promote drugs and food safety in Rwanda.
The €2Million project is funded by the European Union Delegation and implemented by Expertise France, a French technical cooperation Agency with the help of different health agencies of the European partner countries.
The two year twinning project involves several vaccines and medicines regulatory agencies from EU Member States such as the French National Agency for the Safety of Medicines and Health Products (ANSM), Paul-Ehrlich-Institut – German Federal Institute for Vaccines and Biomedicines, Sciensano of Belgium and the State Medicines Control Agency of Lithuania.
“This project will be ongoing and it supports Rwanda’s bid to produce vaccines which are in the pipeline as we plan to start manufacturing vaccines soon,” said Yvan Butera, the Rwandan Minister of State in the Ministry of Health.
Butera added that the project is vital as Rwanda FDA needs support in the medicine regulatory framework and upholding international vaccine production standards.
This will improve FDA laboratory services, enhancing its capacity for risk assessment, and promoting the use of international standards and best practices,” he said.
The project is expected to improve the enabling environment for regulation of medicinal products and vaccines in the country through three components: Improving legal framework and regulatory functions linked to medicinal products; Strengthening of market surveillance and control function – vigilance & laboratory testing functions; and Support the establishment of the official batch release function for vaccines.
It is expected that about 200 experts will be able to support the Rwanda FDA through field visits during which they will share their expertise with designated Rwanda FDA Staff.
The project team consists of experts from health agencies from the European member states which are part of the twinning who will work together with Rwanda FDA Staff to achieve the project objectives.
Officials from the delegation of the European Union commended the initiative that will enable Rwanda FDA to strengthen its regulatory framework and improve food safety in Rwanda, which is essential for protecting public health and promoting economic growth.
EU Ambassador to Rwanda, Belén Calvo Uyarra said that there is an investment commitment considering a lot of future opportunities for the EU partners to invest more than the initial €2Million investment, especially looking at the vaccine ecosystem in Rwanda where BioNTech is already investing.
The groundbreaking ceremony for BioNTech’s initial African modular mRNA manufacturing facility located in the Kigali Special Economic Zone (KSZE) in Gasabo district, in Kigali was held in June 2022.