Warsaw, 10 February, Representatives of the Botswana Medicines Regulatory Authority (BoMRA) visited the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL) in Warsaw, Poland. The meeting concluded with the signing of a Memorandum of Understanding (MoU) between the two authorities.
This milestone marks an important step in strengthening international cooperation in the regulation of medicinal products and medical devices. The President of the Office for Registration of Medicinal Products, Dr. Grzegorz Cessak, hailed the visit as historic the first ever by representatives of an African National Regulatory Authority (NRA) to the URPL office. Its significance was further enhanced by the formalisation of cooperation through the Memorandum of Understanding.
The MoU highlights the commitment of both authorities to long-term cooperation across multiple regulatory areas and establishes a broad framework for collaboration, including:
• Exchange of knowledge and experience in the marketing authorisation of medicinal products
• Cooperation in pharmacovigilance systems
• Regulatory support and oversight of clinical trials
• Exchange of information on medicinal product shortages and preventive measures
• Regulation and supervision of medical devices
• Organisation of joint workshops, conferences, study visits, and expert consultations
• Collaboration on regulatory harmonisation and the protection of public health
• Establishment of mechanisms for regular working-level meetings and designation of contact points responsible for coordinating ongoing cooperation
A Strategic and Long-Term Partnership
The Office for Registration of Medicinal Products views this cooperation as extending beyond the duration of the current collaboration between the two authorities, supported by the European Medicines Agency (EMA) project, “Medicines Regulatory Systems Strengthening in Sub-Saharan Africa.” Participation in this initiative provides BoMRA with an opportunity to build lasting institutional links to support the Authority’s capacity-building and reliance and recognition initiatives.
Both institutions share a common objective: strengthening regulatory systems to safeguard public health and ensure access to safe, effective, and high-quality medicinal products and medical devices.
The signed Memorandum of Understanding (MoU) forms part of the broader project “Medicines Regulatory Systems Strengthening in Sub-Saharan Africa,” implemented under the European Medicines Agency grant programme in collaboration with BoMRA and the Ethiopian Food and Drug Authority. This project is part of the Team Europe initiative, which aims to strengthen regulatory systems worldwide through coordinated action by European institutions, the exchange of knowledge and best practices, and the development of sustainable regulatory competencies.
