The European Commission, the European Medicines Agency (EMA) and the United States (US) Food and Drug Administration (FDA) have had confidentiality arrangements in place since 2003, allowing for the exchange of confidential information as part of their regulatory and scientific processes. The European Union (EU) and the United States (US) have also put in place a mutual recognition agreement (MRA) on good manufacturing practice (GMP) inspections.
The arrangement allows the exchange of confidential information on regulatory and scientific processes, including information relating to:
- scientific advice;
- orphan designation;
- paediatric development;
- GMP and good clinical practice (GCP) inspection planning and reports;
- marketing authorisation procedures;
- changes to marketing authorisations;
- post-marketing surveillance.
The current arrangement was signed in 2010 and is now effective for an indefinite period without the need to be renewed:
- Statement of authority and confidentiality commitment from the EMA not to publicly disclose non-public information shared by the US FDA (15/09/2010)
- Statement of authority and confidentiality commitment from the US FDA not to publicly disclose non-public information shared by the EMA (15/09/2010)
EMA and the FDA have agreed specific implementation plans of the confidentiality arrangement for human and veterinary medicines:
- Confidentiality arrangements concluded between the EU (European Commission and EMA) and the US FDA / Department for Health and Human Services - Implementation plan for medicinal products for human use
- Confidentiality arrangements concluded between the EU (European Commission and EMA) and the US FDA / Department of Health and Human Services - Implementation procedures for veterinary medicinal products cluster
MRA and collaboration on GMP compliance
The European Union (EU) and the United States (US) regulators have signed an MRA on GMP inspections, which enters into force on 1 November 2017 and will be in transition phase until July 2019.
The aim is to encourage greater international harmonisation, make better use of inspection capacity and reduce duplication. For more information and the scope of the EU-US MRA, see Mutual recognition agreements (MRA).
To facilitate the implementation of the MRA, EMA, the European Commission and the FDA signed a confidentiality commitment in August 2017, which allows the FDA to share full inspection reports of medicine manufacturers, including trade secret information with EU regulators:
- Statement of authority and confidentiality commitment from the European Commission's Directorate-General for Health and Food Safety and EMA not to publicly disclose non-public information shared by the US FDA (23/8/2017)
- Statement of authority and confidentiality commitment from the US FDA not to publicly disclose non-public information shared by the European Commission's Directorate-General for Health and Food Safety and EMA (23/8/2017)
The arrangement complements the existing EU-US confidentiality arrangement in the area of GMP inspections.
This allows the two agencies to make decisions based on findings in each other's inspection reports and to make better use of their inspection resources to focus on manufacturing sites of higher risk.
EMA and FDA had run bilateral collaborative activities in the area of GMP inspections, which contributed to building trust and increase confidence in each other's activities, allowing the MRA to be fully implemented. These include:
- EMA / FDA joint GMP inspection pilot programme . The programme concerns finished product sites;
- Enhancing GMP inspection cooperation between the EMA and FDA . The initiative includes work-sharing on inspections of manufacturing sites in each other's territories;
- Mutual reliance initiative between the US FDA and the EU on GMP inspections. This is the most recent, launched in May 2014.
Regular meetings are organised and inspection plans and outcomes may be shared.
The FDA participates in the international active-pharmaceutical-ingredient inspection programme. The programme aims to increase cooperation and mutual reliance between regulators participating in the initiative as well as to ensure the best use of inspection resources worldwide.
For more information, see:
In addition, the Agencies hold quarterly teleconferences on drug shortages due to GMP non-compliance and quality defects since 2013, with the participation of Health Canada and TGA. The aim of this interaction is to develop international co-operation to share information on specific shortages (with or without impact on other territories) and best practices on risk management and prevention strategies.
The agencies hold regular meetings by phone or videoconference 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 on cluster activities, see
Interactions in the area of good clinical practice inspections
EMA and FDA are engaged in two main collaborative activities in the area of good-clinical-practice (GCP) inspections:
- EMA / FDA GCP Initiative .
- EMA / EU Member States-FDA initiative on inspections for generic applications . This initiative focuses on bioequivalence inspections.
These initiatives aim to reduce the duplication of inspections, to influence inspection decision-making process (triggering/cancelling inspections) and to get a better understanding of each other's inspection procedures and processes. The participants meet regularly via teleconference and also interact on an ad-hoc basis.
For more information, see:
Quality by design
In March 2011, EMA and the FDA launched a pilot programme for the parallel assessment of sections of applications that are relevant to quality by design, originally for three years. Following a successful first phase, the Agencies extended the pilot for a further two years as of 1 April 2014.
The objective of this programme is to share knowledge, facilitate a consistent implementation of the international guidelines on quality by design aspects and promote the availability of pharmaceutical products of consistent quality throughout the EU and the US. There are two modalities for participation: parallel assessment (the application is submitted in parallel to both agencies) or consultative advice (the application is submitted either to EMA or FDA, which may request 'consultative advice' from the other party). PMDA may participate as an observer in the programme.
For more information, see the Quality by design page.
Parallel scientific advice
The Agency provides scientific advice and protocol assistance in parallel with the FDA:
Transatlantic Administrative Simplification Action Plan
The Transatlantic Administrative Simplification Action Plan was set up in 2007 to remove administrative burden in the interaction between medicines regulators in Europe and in the US while maintaining levels of public-health protection.
Implementation reports summarising the plan's 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 report on interactions between the FDA and the EMA, published in 2010.
Transatlantic Taskforce on Antimicrobial Resistance
The Transatlantic Taskforce on Antimicrobial Resistance (TATFAR) was created in 2009 with the goal of improving cooperation between the US and the EU in three key areas:
- appropriate therapeutic use of antimicrobial drugs in medical and veterinary communities;
- prevention of healthcare and community-associated drug-resistant infections;
- strategies for improving the pipeline of new antimicrobial drugs.
- The Centers for Disease Control and Prevention of the United States currently provides the secretariat for the task force and publishes documents related to its work on a dedictaed TATFAR webpage. The European Centre for Disease Prevention and Control provided the secretariat from 2009-2013.
More information on EMA-FDA interactions
The FDA and EMA have seconded liaison officials to each other's premises for several years, based on a terms of reference published in 2009.