Premature Filings Add To EU Regulatory Resource Challenge

The pharmaceutical legislation overhaul offers some solutions to the problem of immature applications.

Staff Shortages — EMA and national regulatory authorities face challenges in recruiting new staff • Source: Shutterstock

With the COVID-19 pandemic declared over, the biggest challenge facing the European Medicines Agency is the “sustainability of our medicines regulatory network” due to a lack of resources, including staff, according to the EMA’s chief medical officer, Steffan Thirstrup. Exacerbating the problem are premature marketing applications from drug companies that divert precious resources, he said.

The comments came at a fireside chat at the TOPRA (The Organization for Professionals in Regulatory Affairs) Symposium in Lisbon,...