EMA Board discusses regulatory science and new challenges posed for drug development

The European Medicines Agency’s Management Board held its first meeting in 2013 on March 20-21 March. The first day was dedicated to reflections on regulatory science and on the best way to get the European medicines network ready to address the challenges of the fast-evolving area of drug development. The focus of the second day was on reporting on activities of the past year and forward planning for 2014 and beyond.

“Medicines regulation today is characterised by the increasing complexity of applications for new medicines, such as nanomedicines or personalised medicines, and the drug-development environment as a whole,” explained the Agency’s executive director Guido Rasi.

The Board agreed that there is a need to develop the capability of the European medicines network to assess innovative study designs. An innovative evaluation framework involving iterative phases of data gathering and regulatory evaluation is needed in order to align regulatory approval more closely with patients’ needs for timely access to innovative medicines. This also includes the ability to integrate in the decision-making process multiple data sources - not only industry studies but also data from real-world use, as well as the views of patients on the level of risk acceptable for a given medical benefit. Some initiatives to address these topics are already included in the Agency’s 2013 work