United States

The European Commission, the European Medicines Agency (EMA) and the United States of America (USA) Food and Drug Administration (FDA) work together in many areas, streamlining efforts, sharing best practices and aiming to avoid duplication to promote human and animal health. Confidentiality arrangements facilitate this collaboration.

Confidentiality arrangements

20 years of EU / US collaboration on medicines regulationThe European Commission, EMA and FDA have confidentiality arrangements in place since 2003. These permit the exchange of unredacted, commercially confidential information relating to regulatory and scientific processes.

The confidential information exchanged covers the whole lifecycle of medicinal products for human and veterinary use. It includes:

• applications for scientific advice, orphan designation, marketing authorisation and post-authorisation variations;
• applications for agreement of paediatric investigation plans;
• good manufacturing practice (GMP) and good clinical practice (GCP) inspection planning and reports;
• pharmacovigilance data, such as in relation to adverse drug reactions, safety concerns arising from periodic safety update reports, post-authorisation obligations and commitments, and inspection reports;
• legislation and guidance documents.

For more information, see:

20 years of EU / US collaboration on medicines regulation

Confidentiality arrangement 2010

It was signed in 2010 and is effective for an indefinite period:

• Statement of authority and confidentiality commitment from the European Medicines Agency not to publicly disclose non-public information shared by the United States Food and Drug Administration (15/09/2010)
•  Statement of authority and confidentiality commitment from the United States Food and Drug Administration not to publicly disclose non-public information shared by the European Medicines Agency (15/09/2010)

Confidentiality arrangement 2017

This arrangement allows FDA to share full inspection reports of medicine manufacturers, including trade secret information with EU regulators. It complements the existing confidentiality arrangement:

• Statement of authority and confidentiality commitment from the European Comission's Directorate-General for Health and Food Safety and the European Medicines Agency (EMA) not to publicy disclose non-public information sh... (23/08/2017)
• Statement of authority and confidentiality commitment from the United States Food and drug Administration (FDA) not publicly disclose non-public information shared by the European Commission's Directorate-General for Hea... (23/08/2017)

Cluster activities

EMA and FDA, together with other non-EU regulators, hold regular virtual meetings in so-called 'clusters', which are areas of cooperation focusing on special topics and therapeutic areas identified as requiring an intensified exchange of information and collaboration.

For more information about existing platforms of interaction, see:

• Cluster activities with regulatory partners
• Are the European Medicines Agency, US Food and Drug Administration, and Other International Regulators Talking to Each Other?

Mutual recognition agreement and GMP compliance

The EU and the USA signed a mutual recognition agreement (MRA) on good manufacturing practice (GMP) inspections. This allows EU authorities and their FDA counterparts to:

• rely on each other's GMP inspections for some types of medicines;
• waive batch testing of products on entry into their territories;
• share information on inspections and quality defects.

For more information on MRAs and the scope of the EU-USA MRA, see:

• Mutual recognition agreements

EMA also participates in initiatives with FDA on GMP inspections. International collaboration aims to make efficient use of inspection capacity globally, enabling wider monitoring of manufacturing sites and reducing duplication between regulatory authorities.

For more information, see:

• International collaboration on GMP inspections

Parallel scientific advice

EMA and FDA have a programme to provide parallel scientific advice to interested applicants. It allows EU authorities and their FDA counterparts to:

• exchange views on scientific issues with companies during the development phases of medicinal products;
• deepen understanding of scientific and regulatory decisions;
• optimise medicine development and avoid unnecessary duplication.

Parallel scientific advice is available for medicines for human use and medicines for veterinary use.

For more information, see:

• Parallel scientific advice

Liaison officials

FDA and EMA routinely assign liaison officials to each other’s premises since 2009.

The liaison officials:

• serve as focal points between EMA and FDA;
• foster collaboration;
• identify areas for further regulatory and scientific collaboration.

Fellowships

EMA and FDA have established a fellowship programme on specific topics, allowing the agencies to share best practices, enhance mutual understanding and work together more closely.

For more information, see:

• Fellowships