United States

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 Agency 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;
  • 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;
• influenza-pandemic preparedness.

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;
• 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 for 2009 and 2010:

• Implementation report - 2009
• Final report on implementation - 2010

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
• Reports on interactions between the EMA and the FDA
• Orphan medicines
• Paediatric medicines
• Scientific advice
• Pharmacogenomics and biomarkers
• Inspections
• Quality by design
• Transatlantic Administrative Simplification Action Plan

---

Confidentiality arrangements

Back to top

Reports on interactions between the EMA and the FDA

Back to top

Orphan medicines

Back to top

Paediatric medicines

Back to top

Scientific advice

Back to top

Pharmacogenomics and biomarkers

Back to top

Inspections

Back to top

Quality by design

Back to top

Transatlantic Administrative Simplification Action Plan

Back to top