Fee system for regional joint assessment procedures in Africa
This joint position paper covers the perspective from industry on the proposed fee system for regional joint assessment procedures in Africa.
Adequate and appropriate funding are essential to support the effective operation of the African Medicines Regulatory Harmonization (AMRH) program. In recent years, during the COVID-19 pandemic, society has been acutely reminded of the importance of a robust, resourced, efficient, and adaptable regulatory system.
The goal of having a strong regulatory system is to ensure that patients get access to medicines as quickly as possible, by operating regulatory assessment procedures in a predictable, streamlined, and most efficient way.
This requires a fully integrated funding system throughout the lifecycle of a medicine that is built on proportionality and fee-for-service. Such system should consider regulatory activities for coordination of continental procedures under the African Medicines Agency, the coordination of regional Joint Assessment Procedures under regional secretariats and the assessment work carried out by the National Regulatory Medicine Agency (NMRAs).