European Commission/European Medicines Agency - US Food and Drug Administration bilateral: update

22 April 2014

Senior leadership from DG Health and Consumers (European Commission), the European Medicines Agency (EMA) and the United States Food and Drug Administration (FDA) discussed a number of key initiatives at a bilateral meeting which took place in London from 31 March to 1 April 2014. These meetings take place approximately every 18 months. They provide an opportunity to review the broad strategic areas of collaboration for the oversight of safety, efficacy and quality of medicinal products, help to shape and orientate the scope of the routine information and work-sharing interactions between the two Agencies, which now take place on a daily basis (80-90 per month).

This meeting provided an opportunity for the new leadership team at the EMA to meet their counterparts in FDA, as well as a chance to explore the possible impacts of changes in their respective organisations on a number of bilateral projects.

Participants at the meeting discussed a broad range of issues, including:

• drug supply-chain challenges, including efforts to better leverage each other's inspection resources, as well as the opportunities presented by new United States' legislation to explore pathways for more timely sharing of information;
• the creation of an EU-US Identification of Medicinal Products (IDMP) task force to explore the possibility of using and/or adapting the US new substances registration software for use in the European Union (EU), as well as to assess the feasibility of introducing global identification for medicinal products;
• the development of biosimilar medicinal products. Reporting on the work of the biosimilars cluster, the EMA/EC and the FDA reconfirmed their plans to support and facilitate the global development of biosimilars. Emerging guidance in both regions will allow the use of a reference product sourced from the other region when supported by adequate scientific justification, thus facilitating the use of a common clinical data package that may address the requirements of both regions. The involvement of Health Canada in this cluster was welcomed;
• veterinary topics: the EMA and the FDA are seeking to explore opportunities to broaden their cooperation in the area of guidance to applicants with respect to novel veterinary therapies;
• EMA and FDA committed to promote the uptake of parallel scientific advice by the animal health industry, by raising awareness of the services offered in this area with potential applicants;

• On-going cooperation on the recommendations related to veterinary medicines in the Transatlantic Task Force on Antimicrobial Resistance (TATFAR) was recognised, specifically relating to the collection of data on sales of veterinary antimicrobials, exchange of information on the implementation of risk management measures, and on the promotion of prudent use of antibiotics in veterinary medicines. Further cooperation was envisaged on the new recommendation added to TATFAR of identifying knowledge gaps related to the transmission of resistance from the veterinary to the human domain and the effectiveness of control measures to limit this;

• paediatric medicines: EMA and FDA recognised the usefulness of bilateral commentaries on certain applications for paediatric investigation plans (PIPs) in the EU, and paediatric study plans (PSPs) in the United States. Similarities in the respective paediatric application forms for PIPs and PSPs, as well as flexibility in the timing of submission of applications (in duly justified cases), will continue to be explored;
• pharmacovigilance: both agencies noted that the establishment of the EMA-FDA pharmacovigilance cluster in 2013 had been a success, bringing added value in particular in the areas of information exchange and scientific, procedural and communication planning discussions. Following the success of an EMA/FDA signal exchange on vaccines initiated in January 2013, both sides expressed a desire to continue this activity.