What new Rwanda-France cooperation on medicines regulation means
Thursday, June 27, 2024
Dr Emile Bienvenu, Rwanda FDA Director-General and representative of the French National Agency for Medicines and Health Products Safety (ANSM) during the signing event on June 20. Courtesy

Rwanda Food and Drugs Authority (FDA) and the French National Agency for Medicines and Health Products Safety (ANSM) are looking to enhance cooperation in the regulation of medicines and vaccines following the signing of a Memorandum of Understanding (MoU) on June 20.

The agreement will offer capacity-building opportunities related to the regulation of medicines, and other health technologies and support initiatives connected to information and technology systems, in addition to opening doors for jointly mobilising funds for common projects, according to Rwanda FDA.

It is a commitment to consolidate the existing cooperation between Rwanda FDA and the French regulatory agency as contribute to the well-being of the two countries’ populations, officials said.

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"The signing of this MoU will ensure the sustainability of the cooperation that was initiated with ANSM through the collaboration with European Union Member States Medicines Regulatory Agencies,” said Dr Emile Bienvenu, Rwanda FDA Director-General.

"Areas of cooperation include regulatory functions such as product registration, regulatory inspections, laboratory testing, clinical trial oversight, pharmacovigilance (drug safety), and post-market surveillance,” he said.

Bienvenu explained that the agreement established the cooperation on exchange of information and best practices.

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

Bienvenu stated 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, he stressed.

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.

The agency also regulates the production of processed foods, poisons, medicated cosmetics, medical devices, household chemical substances, tobacco and tobacco products.