Representatives from DG Health and Consumers (European Commission), European Medicines Agency (EMA) and the American agency 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 periodically to focus on strategic areas of collaboration for the oversight of safety, efficacy and quality of medicinal products, and to orientate information and work-sharing activities between the two medicine Agencies.
Participants at the meeting discussed a broad range of issues, including:
• aspects related to the drug supply-chain challenges
• 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
• plans to support the global development of biosimilar medicinal products
• concerted actions in paediatrics: 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.
• pharmacovigilance aspects: following the success of the EMA-FDA pharmacovigilance cluster in 2013, a plan to continue collaboration in this field is going to be developed
• veterinary topics
For further information, visit the EMA website.
