FDA, European Commission and EMA jointly establish strategic priorities

The US Food and Drug Administration, the European Commission and the European Medicines Agency have reviewed their cooperation, especially regarding pharmacovigilance, biosimilars and pediatric medicine.

The three bodies have significantly increased their level of collaboration and information-sharing over the past few years, undertaking daily interactions.

At the bilateral meeting held in the FDA headquarters, they set out their strategic priorities, including establishing a new cluster on patient engagement to share experiences and best practice regarding the involvement of patients in medical development, evaluation and post-authorization activities. The three bodies are also to strengthen their collaboration on inspections and data integrity, safety monitoring of medicines, biosimilars, pediatric medicines, rare diseases and timely access to new medicines.