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The European Union (EU), including the European Commission and the European Medicines Agency (EMA), has had confidentiality arrangements with the United States (US) Food and Drug Administration (FDA) since September 2003. The arrangements allow the exchange of confidential information between the EU and the FDA as part of their regulatory and scientific processes. This includes information on advance drafts of legislation and regulatory guidance documents, as well as non-public information related to ensuring the quality, safety and efficacy of medicinal products for human and veterinary use.

The EMA and the FDA share information on marketing-authorisation procedures, changes to marketing authorisations and post-authorisation surveillance for products under review both in the US and in the EU, through:

  • the exchange of assessment reports and review documents;
  • regular tele- and videoconferences on specific topics and classes of medicines, such as oncology, orphan medicines, paediatrics, vaccines, blood products, pharmacogenomics, advanced therapies, veterinary medicines and biosimilar medicines;
  • ad hoc teleconferences between US and EU experts.

The two agencies have developed common procedures for good-manufacturing-practice and good-clinical-practice inspections and for applications for orphan designation. They also share information on pharmacovigilance, scientific advice, biomarkers, inspection planning and reporting and preparedness for pandemic influenza.

Other developments have included the launches of:

  • a three-year pilot, starting in April 2011, allowing the parallel evaluation of 'quality by design' aspects of applications submitted to the EMA and the FDA at the same time. Quality by design is an enhanced systematic and science-based approach to the development and manufacture of medicines that ensures better quality of medicines. In August 2013, they published a joint question-and-answer document that outlines the conclusions of their first parallel assessment of quality-by-design elements of a marketing-authorisation application. Both agencies found the parallel assessment extremely useful and reached agreement on a wide range of aspects;
  • an initiative to share work on inspections of manufacturing sites in each other's territories, starting in January 2012.

The confidentiality agreements between the EU and the FDA were extended in 2005 and again in 2010. They are now effective for an indefinite period without the need for further renewal.

The EMA and the FDA publish an annual report summarising their interactions.

Transatlantic Administrative Simplification Action Plan

The Transatlantic Administrative Simplification Action Plan aims to remove administrative burden in the interaction between medicines regulators in Europe and in the US. It supports the interaction between the EMA and the FDA, while maintaining levels of public-health protection.

The plan was set up by the European Commission and the FDA in November 2007, with the collaboration of the EMA and the Heads of Medicines Agencies. The plan was published in June 2008 and outlines 15 projects.

Implementation reports summarising the plan's progress and activities are available:

The agencies have now completed most of the projects in the original plan. Ongoing developments and new initiatives in transatlantic administrative simplification are now included in the annual reports on interactions between the FDA and the EMA.

Representation at the EMA and the FDA

Since 2009, the FDA has seconded a permanent representative to the EMA's office in London. Since early 2010, the EMA has seconded a representative to the FDA's offices.

Table of contents


Confidentiality arrangements

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Document(s) Language Status First published Last updated Effective Date
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 (English only)   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 (English only)   15/09/2010    
Confidentiality arrangements concluded between the European Union (European Commission and European Medicines Agency) and the United States Food and Drug Administration / Department of Health and Human Services - Implementation procedures for veterinary medicinal products cluster (English only)   22/05/2008    
Confidentiality arrangements concluded between the European Union (European Commission and European Medicines Agency) and the United States Food and Drug Administration / Department for Health and Human Services - Implementation plan for medicinal products for human use (English only)   18/06/2007    
Extension of confidentiality arrangement between the United States Food and Drug Administration and the European Commission Enterprise and Industry Directorate-General and the European Medicines Agency to exchange regulatory information (English only)   15/09/2005    
Confidentiality arrangements concluded between the European Union (European Commission and European Medicines Agency) and the United States Food and Drug Administration / Department of Health and Human Services - Implementation plan for medicinal products for human use (English only)   16/09/2004    
Letter from the Food and Drug Administration to the European Commission (English only)   12/09/2003    
Letter from the European Medicines Agency and the European Commission to the Food and Drug Administration (English only)   12/09/2003    

Reports on interactions between the EMA and the FDA

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Document(s) Language Status First published Last updated Effective Date
Interactions between the European Medicines Agency and United States Food and Drug Administration September 2009-September 2010 (English only)   23/06/2011    

Orphan medicines

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Document(s) Language Status First published Last updated Effective Date
Common European Medicines Agency / Food and Drug Administration application form for orphan-medicinal-product designation (English only)   24/11/2008    

Paediatric medicines

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Document(s) Language Status First published Last updated Effective Date
Principles of interactions between the European Medicines Agency and the Food and Drug Administration paediatric therapeutics (English only)   18/06/2007    

Scientific advice

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Pharmacogenomics and biomarkers

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Inspections

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Document(s) Language Status First published Last updated Effective Date
EMA-EU MSs-FDA initiative on inspections for Generic Applications: Terms of engagement and procedures for participating authorities (English only)   18/12/2013    
Programme to rationalise international good-manufacturing-practice inspections of active-pharmaceutical-ingredient / active-substance manufacturers: Terms of reference and procedures for participating authorities (English only)   06/03/2012    
Enhancing good-manufacturing-practice-inspection cooperation between the European Medicines Agency and the Food and Drug Administration (English only)   09/12/2011    
Report on the pilot European Medicines Agency-Food and Drug Administration good-clinical-practice initiative (English only)   02/08/2011    
Final report on the international active-pharmaceutical-ingredient-inspection pilot programme (English only)   02/08/2011    
European Medicines Agency / Food and Drug Administration joint good-manufacturing-practice-inspection pilot programme - General principles (English only)   15/11/2010    
European Medicines Agency / Food and Drug Administration joint good-manufacturing-practice-inspection pilot programme - Terms of reference and procedures for participating authorities (manufacturers of medicinal products) (English only)   15/11/2010    
Interim report on the international active-pharmaceutical-ingredient-inspection pilot programme (English only)   01/10/2010    
United States Food and Drug Administration - European Medicines Agency: Good-clinical-practice initiative: Frequently asked questions and answers (English only)   08/04/2010    
European Medicines Agency-Food and Drug Administration good-clinical-practice initiative (English only)   31/07/2009    
Update on a pilot project to collaborate on international good-manufacturing-practice-inspection activities (English only)   08/01/2009    
Rules of engagement and procedures for participating authorities (active pharmaceutical ingredients / active substances) (English only)   07/01/2009    
Outline of a pilot project to rationalise international good-manufacturing-practice-inspection activities (English only)   06/11/2007    

Quality by design

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Transatlantic Administrative Simplification Action Plan

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Document(s) Language Status First published Last updated Effective Date
Transatlantic Administrative Simplification Action Plan – Final report on implementation (English only)   29/07/2011