The ministry of health has welcomed the EU-funded project dubbed “Twinning project” to strengthen the Rwanda Food and Drugs Authority in regulating medicinal products including vaccines. The Ꞓ2milion (approx Rwf2.5billion) funding aims to promote drugs and food safety in Rwanda.
The project seeks to improve its laboratory services, enhancing its capacity for risk assessment, and promoting the use of international standards and best practices.
Dr. Yvan Butera, State Minister in the Ministry of Health said that as the government of Rwanda seeks 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, improved standards for vaccine production are needed.
“One of the country’s strategies to address this objective is to enhance the domestic value chain for pharmaceutical and vaccine manufacturing, which requires strengthening the national regulatory framework,” he said, stressing the need for strengthening Rwanda Food and Drugs Authority’s regulatory functions related to medicinal products including vaccines.
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.
“This 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,” the Minister of state 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.
Rwanda will soon start producing vaccines which requires regulatory procedures in place for future vaccine manufacturing.
On March 13, this year, Rwanda acquired the six ISO-sized shipping containers for the first BioNTainer constructed in Europe aimed at scaling the production of vaccines in Africa.
BioNTech’s first modular factory is made out of shipping containers. Dubbed a BioNTainer, the factory was built in Europe and inspected by the company’s manufacturing experts.
Roughly, each BioNTainer consists of one drug substance and one formulation module for a total footprint of about 800 square meters.
The units will be able to crank out about 50 million doses a year of BioNTech’s Pfizer-partnered COVID-19 vaccine, according to company’s executives.
The Kigali site is expected to hire a staff of 100 by 2024. BioNTech has said vaccine production should begin within a year of delivery of the BioNTainers.