Senior leaders from the United States Food and Drug Administration (FDA), the European Commission and the European Medicines Agency (EMA) reviewed their ongoing cooperative activities and discussed strategic priorities for the next two years at their regular bilateral meeting held on 19 June 2015, at FDA Headquarters in Silver Spring, Maryland, USA.

Over the past years, EMA and FDA have significantly increased their level of collaboration and sharing of information to advance regulatory excellence worldwide. There are now daily interactions, most of them structured around scientific and regulatory working groups or “clusters”. The focus of the cluster reviews during this bilateral was pharmacovigilance, biosimilars, paediatrics and veterinary medicines.

Looking ahead, EMA, European Commission and FDA decided to establish a new cluster on patient engagement to share experience and best practices regarding the involvement of patients in the development, evaluation and post-authorisation activities related to medicines.

Participants also agreed that communication on the ongoing successful cooperation should be enhanced and that efforts to support communication activities and align core messages should be strengthened.

For more details, go to: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2015/07/news_detail_002367.jsp&mid=WC0b01ac058004d5c1