FDA, EMA to Collaborate on Patient Engagement in Drug Development

The FDA and its European counterpart will establish a joint patient engagement working group to share best practices on involving patients in drug development and monitoring.

The FDA and European Medicines Agency also plan to expand collaboration on inspections, data integrity, safety monitoring, biosimilars, pediatric drugs, rare diseases and timely access to new drugs.

In the area of pediatric drugs, the EMA and FDA will continue to align their approaches to clinical trials. To increase use of each other’s inspection findings and free up investigators to inspect more facilities, the two regulators are comparing inspectorates and regulatory frameworks, the EMA said last week.

Since signing a confidentiality agreement in 2003, the FDA and EMA have collaborated on inspections for generic applications and conducted a joint quality by design pilot aimed at evaluating QbD applications on a parallel basis, among other activities. — Jonathon Shacat