Rwanda FDA kick-starts €2m Twinning project to improve medicinal products

Rwanda Foods and Drugs Auhtority has welcomed the EU-funded project dubbed “Twinning project” to strengthen the Authority in regulating medicinal products including vaccines.

The project launched on May 16, 2023 aims to promote drugs and food safety in Rwanda.

The launch brought together key stakeholders in the health sector, including government officials, health industry representatives, civil society organizations, and development partners.

The project was funded by the European Union Delegation and is implemented by Expertise France, a French technical cooperation Agency with the help of different health agencies of the European partner countries of the twinning.

The two-year project, to be implemented at the cost of 2 million Euros, seeks to improve its laboratory services, enhancing its capacity for risk assessment, and promoting the use of international standards and best practices.

The 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.

Speaking during the launch, Dr. Yvan Butera, State Minister in the Ministry of Health commended team Europe for the continuous support and effort rendered to the health sector in Rwanda.

“A main priority for the Government of Rwanda is to strengthen health systems at all levels of service delivery in order to ensure universal accessibility of equitable and affordable quality health services for all Rwandans,” he said.

One of the country’s strategies to address this objective, he said, is to enhance the domestic value chain for pharmaceutical and vaccine manufacturing, which requires strengthening the national regulatory framework.

“This is the overall goal of this EU Twinning Project, which aims at strengthening Rwanda FDA’s regulatory functions related to medicinal products including vaccines,” he noted.

The project also looks at Strengthening of market surveillance and control function – vigilance and laboratory testing functions as well as supporting the establishment of the official batch release function for vaccines.

“The launch of this twinning project, which follows the agreement that was signed in June 2022, is a major step toward realizing the country’s goals of ensuring equitable and affordable access to quality health services for all Rwandans through quality regulation of medical products,” Minister of state said.

Since its implementation in October 2022, this twinning program has enabled the regulatory body-Rwanda FDA to adapt best practices borrowed from sister European regulatory agencies to Rwanda context, he said.

“We have no doubt that Rwanda FDA will keep up-to-date with the current innovations and developments in technology within the regulatory environment globally,” he added.

He appreciated the efforts deployed through the European Commission by the consortium partner countries to support the Republic of Rwanda in strengthening its medicines’ regulatory framework.

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.

It is set to provide the Rwanda FDA with access to support from EU National Regulatory Agencies.

EU Ambassador to Rwanda, Belén Calvo Uyarra said: “EU is a proud partner of Rwanda in manufacturing and access to vaccines, medicines and health equity.”

“In Sub-Saharan Africa, no other Twinning cooperation has attracted such a sizable consortia. As every Member State involved can bring their own areas of expertise, we are confident that this partnership will bring you the highest possible value,” she noted.

With Rwanda soon to start producing vaccines, this twinning cooperation provides support with a view to ensure Rwanda FDA has the necessary regulatory procedures in place for future vaccine manufacturing, she added.