EU Commission proposal for revised EMA fees regulation welcomed by EFPIA

Pharma lobby group the European Federation of Pharmaceutical Industries and Associations (EFPIA) says it welcomes the opportunity to provide feedback on the European Commission proposal for a revised European Medicines Agency (EMA) Fees regulation.

Speaking about the proposal, Pär Tellner, director regulatory, drug development and manufacturing, at the EFPIA, said: “Industry considers it essential to the viability of the EU regulatory system that the Network be strengthened by the necessary resources, funding, infrastructure and expertise. The EMA fees system functions as a central resource enabler requiring regular updates over time."

The group noted that the COVID-19 pandemic has highlighted the importance of a robust, resourced, efficient, and adaptable regulatory system. Significant resourcing challenges are faced today by the EU regulatory Network and it is essential that EMA and National Competent Authorities (NCAs) have the necessary resources and infrastructure to deliver their public health mission.