Signing of Memorandum of Understanding between Rwanda Food and Drugs Authority (Rwanda FDA) and Ghana Food and Drugs Authority (Ghana FDA)

Rwanda FDA , on 24th 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.  

European Union strengthens capacity of Rwanda FDA through the Twinning cooperation with EU Member State agencies

The European Union on 22nd June, 2022 launched a Twinning cooperation that will provide Rwanda Food and Drugs Authority with a peer-to-peer partnership including several EU Member State regulatory agencies. This Twinning agreement was signed between the Head of Delegation of the European Union to Rwanda, Ambassador Nicola Bellomo and the Ambassador of France to Rwanda Antoine Anfre in the presence of the Minister of Health of Rwanda Dr Daniel Ngamije and Director General of the Rwanda FDA, Dr Emile Bienvenu. France is the lead Member State of the consortia, which is further composed of Germany, Belgium and Lithuania. The Twinning project aims at supporting the Authority improving the enabling environment for regulation of medicinal products and vaccines in the country.

The EU also delivered critical quality control laboratory equipment to the Rwanda FDA, including key integrated information management system equipment, to allow the Authority to establish a more modern Quality Control Laboratory and thereby support its role to ensure the safety, efficacy and quality of vaccines and pharmaceutical products.

BUILDING CAPACITY FOR VACCINE REGULATION

This week, Rwanda FDA’s Director-General, Dr. Emile Bienvenu, received Dr.Brian Chirombo, WHO’s country representative to discuss areas of collaboration in capacity building for vaccine regulation and support towards the Authority’s achievement of Maturity Level 3.

While Rwanda is preparing to initiate vaccine manufacturing in Africa, Rwanda FDA continues to identify and focus on areas of work for regulatory strengthening. The Authority is therefore keeping close collaboration with different partners such as World Health Organisation among others as a strategy increase to support across all its functions

Rwanda FDA is dedicated to delivering high-level services by building a regulatory environment that will capacitate quality assurance of pharmaceutical products as well as local production of vaccines.