Food and drugs authority gets Rwf2bn to boost regulation

The Rwanda Food and Drugs Authority (RFDA) and the European Union on Wednesday, June 22, signed an agreement worth 2 million Euros, aimed at improving the RFDA’s capacity through peer-to-peer partnerships with regulatory agencies of several member states of the EU. The programme will support the RFDA to improve the enabling environment for regulation of medicinal products and vaccines in the country, with support by a consortium led by France, consisting of Germany, Belgium, Sweden, Greece, Austria and Lithuania, to attain the implementation of the agreement. The cooperation will provide the RFDA with access to support from EU National Regulatory Agencies, including expert missions, seminars, workshops, training courses and study visits, to achieve jointly established objectives. The EU also delivered critical quality control laboratory equipment to the RFDA, including key integrated information management system equipment, to allow the regulatory authority to establish a more modern Quality Control Laboratory, to support its work of ensuring the safety, efficacy and quality of vaccines and pharmaceutical products. Dr. Emile Bienvenu, the Director General of the Rwanda FDA signs the agreement as Antoine Anfre, the Ambassador of France to Rwanda (Left) and Nicola Bellomo, the EU Ambassador to Rwanda (c) look on in Kigali on June 22 Nicola Bellomo, the EU Ambassador to Rwanda referred to the deal as “a real Team Europe initiative, bringing together specialized expertise from several EU Member States with RFDA experts.” “It is timely, with the start of the construction of Rwanda’s BioNtech vaccine production plant. Lastly, this is a ground-breaking partnership. It is the first Twinning cooperation between Rwanda and EU Member State public authorities and the first Twinning in the field of health in Sub-Saharan Africa,” he said. Antoine Anfre, the Ambassador of France to Rwanda described the deal as “a very ambitious and timely” one. “France together with Belgium, Germany and Lithuania is proud to be part of this Twinning Agreement, which will enable Rwanda to become a manufacturing hub for drugs and vaccines,” he said. Antoine Anfre, the Ambassador of France to Rwanda (Left) and Nicola Bellomo, the EU Ambassador to Rwanda sign the MoU on in Kigali on June 22.courtesy “The regulatory aspects are crucial in this field. I am confident the forthcoming close partnership between Rwanda Food and Drugs Authority (Rwanda FDA) and French Agence Nationale de Sécurité du Médicament (ANSM), German Paul Ehrlich Institute, Belgian Sciensano and Lituanian State Medicines Control Agency is a game changer. Congratulations and thanks to the EU Delegation, the operator Expertise France and the Government of Rwanda for their respective achievements in this process,” he added Dr. Daniel Ngamije, the Minister of Health described the cooperation as crucial to support Rwanda’s medicine’s regulatory framework. “The Government of Rwanda appreciates the efforts deployed through European Commission by the consortium partner countries (France, Germany, Belgium, and Lithuania) to mobilize their best Health and Regulatory Institutions as well as expertise from other three EU Member States (Sweden, Greece and Austria) to support the Republic of Rwanda in strengthening its medicines’ regulatory framework. Rwanda looks forward to the implementation of this cooperation and is committed to use the laboratory equipment from the EU team to deliver efficient laboratory services especially in the regulation of vaccines,” he said. Dr. Emile Bienvenu, the Director General of the RFDA said the project comes at the right time when Rwanda is already on the road to vaccine manufacturing, which requires strengthening the regulatory capacity of Rwanda FDA. “This project therefore aims at supporting the strengthening of Rwanda FDA’s regulatory framework. Through the EU financial support, Rwanda FDA has also received laboratory equipment. The equipment received under this consignment will increase the capacity of our quality control laboratory as we move into regulation of vaccines which is one of the Authority’s priorities as of today, “ he said.

News

Food and drugs authority gets Rwf2bn to boost regulation