Rwanda-Ghana: Bilateral agreement to establish collaboration in vaccine manufacture regulatory oversight

By Elias Hakizimana.

Rwanda Food and Drugs Authority (Rwanda FDA) and Ghana Food and Drugs Authority (Ghana FDA) have signed a memorandum of understanding (MoU) to begin collaboration in vaccine manufacture regulatory oversight.

The Official signing ceremony of this MoU has taken place in Kigali at Rwanda FDA headquarters on Friday, June 24, 2022.

The MoU 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.

The MoU has been 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 Rwanda’s Minister of state in charge of Primary Healthcare Dr. Tharcisse Mpunga.

“This agreement is to ensure collaboration of vaccines manufacturing up to the finishing level, it will not look at only the vaccines but also other medicines. Indeed, it will fill the gap in vaccines and drugs availability.” Dr Mpunga said.

To support the vaccine manufacturing agenda at the country level, Rwanda FDA has to attain World Health Organisation maturity level 3 which is a prerequisite level for Rwanda FDA set by World Health Organisation 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.” Said Dr. Emile Bienvenu, Director General, Rwanda FDA.

“It is incredible that we are strengthening our collaboration with Ghana FDA since they have already attained ML3, this shows that we are on the right path. Ghana FDA has already been assisting us with reviewing some of our documents and evaluating the level of preparedness, since our self-benchmarking which was conducted last year in September,” he added.

Delese Mimi Darko, Chief Executive Officer of Ghana FDA said that this kind of regulation will strengthen each party.

“As regulators, the more we strengthen each other, the better it is for the medicine security, we cannot set in a respective country and expect that if one country is low in regulations it will affect another, it is good for us as regulators to strengthen each other to ensure the safety of medicine.” She said.  

According to Dr, Daniel Ngamije, Rwanda’s Minister of Health, the move will push regulatory oversight to an advanced maturity level.

 “The government of Rwanda in collaboration with different partners is at the end stage of establishing a high-end vaccine production based on novel technologies and manufacturing processes in Rwanda. One of the building blocks of a sustainable manufacturing facility is a strong regulatory authority thus the government of Rwanda has invested heavily in establishing full functional regulatory infrastructures to facilitate the establishment and control of vaccine production. The implementation of this memorandum of understanding will therefore move the regulatory oversight to another level.” Dr. Ngamije said.

The MoU shall also assess staff capacity requirements including but not limited to Vaccine manufacturing and finishing facilities inspection as well as vaccine quality control.

Rwanda FDA was established by the Law No. 03/2018 of 09/02/2018 determining its mission, organization and functioning. The mandate of the Authority is to protect public health through regulation of human and veterinary medicines, vaccines and other biological products, processed foods, poisons, medicated cosmetics, medical devices, household chemical substances, tobacco and tobacco products.

Ghana FDA is a regulatory agency established under the Ministry of Health by Section 80 of the Public Health Act, 2012 (Act 851) to regulate food, drugs, food supplements, herbal and homeopathic medicines, veterinary medicines, cosmetics, medical devices, household chemical substances, tobacco and tobacco products, and the conduct of clinical trials.

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