FDA vs. EU Inspections: Similarities and Differences

The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) Good Clinical Practice (GCP) initiative started a joint inspection program in September 2009. The program targets investigator sites, sponsors and contract research organizations (CROs) in either the US or the European Union (EU).

 

These joint GCP inspections stem from an arrangement between the European Commission, EMA and the FDA. The initiative allows them to facilitate the conduct of collaborative inspections as well as streamline the sharing of resulting information and observations. The goal is for EU and FDA inspectors to have the same information about a facility.

What are they looking for?

FDA inspections are product specific, i.e., drugs, biologics or medical devices. Investigators follow FDA regulations specifically those found in 21 CFR 312 (Investigational New Drug Application) and 21 CFR 812 (Investigational Device Exemption). During inspections of sponsors, CROs and monitors, FDA compares the practices and procedures conducted by the sponsor or CRO to the commitments outlined in the FDA application.

GCP Inspection Services Group of the EMA handles oversight for the EU. EMA inspections are conducted at the request of their division as a result of a special interest in a particular product or to verify compliance to GCP requirements. Inspectors use the joint program to ensure conformity among member states and to make sure trials are in accordance with recognized agreements among European countries.

Requirements for the conduct of clinical trials in the EU, including GCP, good manufacturing practice (GMP), and the inspections of these trials, have been implemented in the Clinical Trial Directive (Directive 2001/20/EC) and the GCP Directive (Directive 2005/28/EC) as well as other related guidance documents.

 

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