1. EMA-FDA GCP initiative

The Agency and the United States Food and Drug Administration (FDA) agreed to launch a joint initiative to collaborate on international GCP inspection activities in July 2009.

The initiative forms an important contribution to ensuring the protection of clinical-trial subjects in the context of the increasing globalisation of clinical research. The initiative comes under the scope of the confidentiality arrangements between the European Commission, the European Medicines Agency (EMA) and the FDA.

The initiative's main objectives are to:

• conduct periodic information exchanges on GCP-related information, to streamline sharing of GCP inspection planning information, and to communicate on inspection outcomes effectively and in a timely manner;
• conduct collaborative GCP inspections by sharing information, experience and inspection procedures, co-operating in the conduct of inspections and sharing knowledge of best practice;
• share information on the interpretation of GCP, by keeping each other informed of GCP-related legislation, regulatory guidance and related documents, and to identify and act together to benefit the clinical research process.

The initiative began with a pilot phase that ran between September 2009 and March 2011. During the pilot, the EMA and the FDA exchanged more than 250 documents relating to 54 different medicines. They also organised 13 joint inspections of clinical trials in conjunction with the GCP inspectors of the EU Member States.

A report and question-and-answer document on the outcomes of the pilot are available, which detail the success of the information-sharing and collaboration on inspections relating to clinical trials:

The pilot has laid the foundation for a more efficient use of limited resources, improved inspection coverage and better understanding of each agency's inspection procedures. It demonstrates how the agencies can work together to improve human subject protection and better ensure the integrity of data submitted as the basis for drug approvals.

Based on the positive experience, EMA and the FDA intend to continue with the initiative, incorporating lessons learned during the pilot. The Japanese Pharmaceuticals and Medical Devices Agency (PMDA) is an observer of the collaboration as of June 2017.

For more information, see:

Terms of engagement and procedures for participating authorities

Applicants interested in volunteering to take part in a collaborative inspection during the pilot phase should contact the EMA or the FDA.

2. EMA-EU MSs-FDA initiative on inspections for generic applications

In light of the successful implementation of the joint GCP inspections pilot initiative, the EMA, the FDA and the regulatory authorities in some EU Member States agreed to launch a joint initiative to collaborate on the sharing of information and conduct of inspections of bioequivalence studies submitted in support of marketing-authorisation applications for generic medicines. The objectives and the list of EU Member States involved are described in the Terms of engagement for this initiative.

The initiative began with an 18-month pilot phase running between January 2014 and June 2015. A report on its outcome will be made available.