GCP and Bioequivalence Studies: new FDA/EMA Initiative

Recommendation

5-7 November 2024
Hamburg, Germany

GMP meets Development
GMP and FDA Compliance in Pharmaceutical Development and IMP Manufacturing

Back in 2009, the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) implemented an initiative on GCP inspections. Based on the success of this initiative, the scope will now be expanded to include inspections for generic marketing applications.

FDA, EMA but also interested EU Member States (EU MSs) like France, Germany, Italy, The Netherlands and the U.K, have agreed to launch a parallel initiative in the area of inspections of facilities involved in the conduct of bioequivalence studies. In the scope will be companies which have submitted generic marketing applications to the FDA and EMA and/or EU MSs. It will be run separately from the main initiative, but handled in a similar way, starting on 2 January 2014 with an 18-month pilot phase.

The initiative will focus on the following objectives:

• Conduct periodic information exchanges on inspections
• Conduct observed inspections
• Conduct joint inspections
• Provide training opportunities

Source: EMA-EU MSs-FDA initiative on inspections for Generic Applications - Terms of engagements and procedures for participating authorities