EMA Updates Brand, Generic, Biosimilar Guidelines to Mandate Inspection Details

Sponsors of brand, generic and biosimilar drugs applying for marketing authorization through the EU’s centralized procedure must begin including facility inspection information in their applications.

For clinical studies submitted with an application, filers should include a list of good clinical practice inspections conducted or planned by any regulatory authority at the site of all trials included in the submission. Inspections at clinical and analytical facilities where bioequivalence trials were conducted should also be noted, the European Medicines Agency says in updated filing guidelines.

Alternatively, drugmakers should confirm that no inspections have been requested or conducted and that none are planned.

The EMA is also updating the information it wants in applications regarding good laboratory practices.

Drugmakers should include in their drug applications a summary table of information on all nonclinical studies performed, including the study title, code, testing facility and sites, and if the testing was conducted under the auspices of the EU or an Organization for Economic Co-operation and Development Mutual Acceptance of Data monitoring program. — Bryan Koenig