Rwanda Food and Drugs Authority (Rwanda FDA) on June 24, signed a Memorandum of Understanding (MoU) 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 Organisation (WHO) Global Benchmarking Tool (GBT) and technical assistance related to the regulation of medicines and vaccine.

The MoU was signed by the Director-General of Rwanda FDA, Dr. Emile Bienvenu, and Delese Mimi Darko, Chief Executive Officer of Ghana FDA.

It 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.

On hand to witness the signing of the MoU was Rwanda’s State Minister of Health, Dr. Mpunga Tharcisse.

Director-General of Rwanda FDA, Dr. Emile Bienvenu, and Delese Mimi Darko, Chief Executive Officer of Ghana FDA sign the agreement in Kigali on June 24

"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,” said Bienvenu.

Rwanda FDA has to attain World Health Organisation maturity level 3 which is a prerequisite level for Rwanda FDA set by WHO 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.

Mpunga said this memorandum comes after President Paul Kagame and Nana Akufo addo, Ghana president’s commitment to establish a vaccines factory.

He added that this agreement is for the vaccines that will be manufactured in Rwanda to undergo the final stage in Ghana. 

"Though the vaccine factory was established in Rwanda Wednesday, June 24, vaccine production is made of two phases, the first phase which ‘production,’ will take place in Rwanda whereas the second phase which is ‘Fully finishing’ will be done in Ghana,” Mpunga said.

Director-General of Rwanda FDA, Dr. Emile Bienvenu, and Delese Mimi Darko, Chief Executive Officer of Ghana FDA with other officials in group photo after signing the agreement in Kigali. Courtesy

Darko said this agreement will increase the strength of FDA regulators, because the country that is low in regulation will affect other countries.

"The more we strengthen each other, the better it is safer medicine security,” Darko said.

This Memorandum shall establish collaboration in vaccine manufacture regulatory oversight, and assess staff capacity requirements including but not limited to Vaccine manufacturing and finishing facilities inspection as well as vaccine quality control, and lot release.