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.

A team of nine assessors from the World Health Organization have started a 5-days exercise on Monday, December 12, 2022 to benchmark the system for regulating medicinal products in Rwanda against the WHO global benchmarking tool (GBT) indicators and sub-indicators

The objectives of the benchmarking visit are to benchmark the performance of the regulatory system in the areas of medicine and vaccine regulations against the WHO NRA Global Benchmarking Tool (GBT) in Rwanda and measure the maturity of the system. In addition, they will also update the Institutional Development Plan (IDP) of Rwanda FDA and other involved affiliated institutions to address existing and/or potential gaps as well as prioritization of recommendations for implementation to raise the overall maturity of the regulatory system up to level three. Finally, the team will also update the roadmap for regulatory system strengthening of NRA of Rwanda including support from WHO and other interested parties.

Addressing the participants during the launch of the exercise at Rwanda FDA headquarters on Monday, the State Minister in charge of Primary Health Care, Dr. Yvan Butera promised an enhanced support to Rwanda FDA to advance the local manufacturing of vaccines with the aim of advancing bio manufacturing on the whole continent.

“The Government of Rwanda is committed to support Rwanda FDA’s efforts in catalyzing a global dialogue and in collaborating with other regulatory agencies and coalitions, development organizations, academic institutions to identify effective approaches to strengthen the national regulatory systems for medical products,”, he noted.

Rwanda is also committed to ensure high-level services in delivering regulatory interventions for the pharmaceutical field and continues to avail all required resources to Rwanda FDA such as human resources, capacity development, financial, infrastructure, added Minister Butera.

Among the preparations of the formal benchmarking exercise, included the recent passing of the Law Relating to Research on a Human Being in August 2022.

This will be followed by the approval of the Draft Ministerial Order Determining the Functioning Organization and Structure of the Rwanda National Ethics Committee during the upcoming Cabinet meeting.

Delivering his remarks, Professor Emile Bienvenu, the Director General of Rwanda Foods and Drugs Authority, expressed gratitude to the support of World Health Organization in this journey towards the formal benchmarking, which is being launched.

He highlighted that Rwanda FDA received technical assistance of different foams from WHO in February and August 2022, which aimed at building the capacity of Rwanda FDA teams and contributed to addressing formulated IDPs. WHO has significantly assisted Rwanda FDA to improve readiness in all the functions.

“I thank very much the World Health Organizatin for all this support”.

The WHO- Regulatory Systems Strengthening Mission Team Lead, Dr. Alireza Khadem Broojerdi asserted that this should not be called an assessment but rather a peer review.

He indicated that his team will learn a lot from what Rwanda is doing, and commended the government’s efforts towards ensuring the public health of the population through strengthening the regulatory functions of all the medicinal products.

How did it start?

Rwanda FDA attended the WHO workshop for National Regulatory Agencies from the East African Community Partner States held from February 27^th to March 1^st 2018 in Mombasa, Kenya and formal benchmarking was conducted from the 6 to 9 November 2018. 

From the time Rwanda FDA was first benchmarked in 2018, significant progress in Institutional Development Plans implementation was noted and technical support from different experts was provided for all regulatory functions including the Global Benchmarking Tools.

The technical support provided to Rwanda FDA also included a virtual support mission from May 27^th to 28^th 2021 to provide an overview of the WHO computerized Global Benchmarking Tool and to provide a practical demonstration of the latter.

The assisted WHO self-benchmarking conducted in September 2021 highlighted additional gaps that required further technical assistance.  Rwanda FDA then requested support for capacity building from WHO on the assessment of pre-clinical, clinical trials authorization and market authorization, and WHO conducted a mission from the 14 February to 4 March 2022 to provide the requested support.

Further technical support was provided for the regulatory inspection (RI) function and licensing establishment (LI) function from 15 to 18 August 2022. During that mission, additional technical support needs were identified across the remaining six regulatory functions and technical support was provided virtually from 10 to 11 October 2022.

Rwanda FDA , on 24^th June, 2022 signed a memorandum of understanding with Ghana FDA that will allow both National Regulatory Authorities to collaborate in areas of mutual interest, especially in the processes and procedures of the World Health Organization (WHO) Global Benchmarking Tool (GBT) and technical assistance related to the regulation of medicines and vaccine.

To support the vaccine manufacturing agenda at the country level, Rwanda FDA has to attain World Health Organization maturity level 3 which is a prerequisite level for Rwanda FDA set by World Health Organization to allow manufacturers in Rwanda to apply for vaccine prequalification. Rwanda FDA was self-assessed in September 2021 and aims to be formally assessed by WHO by end of 2022. This MoU will therefore see Ghana FDA support Rwanda FDA in the attainment of WHO Global Benchmarking Maturity Level 3 (WHO GBT ML 3) since the latter has already reached Maturity Level 3

The MoU was signed by the Director-General of Rwanda FDA, Dr. Emile Bienvenu, and Delese Mimi Darko, Chief Executive Officer, Ghana FDA. On hand to witness the signing of the MoU was Dr. Tharcisse Mpunga, Minister of State in the Ministry of Health in charge of Primary Healthcare, Dr. Karita Etienne , the Chairman Board of Directors, Rwanda FDA and other dignitaries.