New Rwanda-France cooperation to strengthen medicines regulation

RWANDA – Rwanda Food and Drugs Authority (FDA) and the French National Agency for Medicines and Health Products Safety  have signed a Memorandum of Understanding (MoU) to enhance cooperation in the regulation of medicines and vaccines. 

The agreement aims to consolidate the existing collaboration between the two regulatory agencies and contribute to the well-being of the populations in both countries.

The partnership will offer capacity-building opportunities related to the regulation of medicines, other health technologies, and support initiatives connected to information and technology systems. 

It will also open doors for jointly mobilizing funds for common projects.

Dr. Emile Bienvenu, the Rwanda FDA Director-General, stated that the agreement will ensure the sustainability of the cooperation that was initiated with ANSM through the collaboration with European Union Member States Medicines Regulatory Agencies.

The areas of cooperation include regulatory functions such as product registration, regulatory inspections, laboratory testing, clinical trial oversight, pharmacovigilance (drug safety), and post-market surveillance. 

The agreement also establishes cooperation on the exchange of information and best practices. 

The partnership will last for three years and be renewed for another three years.

Bienvenu explained that the agreement addresses the need to increase Rwanda FDA’s regulatory capacity by providing training, study visits, and support for its staff. 

This will improve their ability to regulate medicines and health technologies effectively, advance medicine accessibility, boost operational efficiency, and promote sustainable practices. 

Established in 2018, Rwanda FDA has the mandate to protect public health through the regulation of human and veterinary medicines, vaccines, and other biological products, as well as the production of processed foods, poisons, medicated cosmetics, medical devices, household chemical substances, tobacco, and tobacco products.

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