The European Medicines Agency’s (EMA) Management Board unanimously adopted a new policy on the publication of clinical reports that underpin the decision-making on medicines. The policy will enter into force on 1 January 2015 and will apply to clinical reports supporting all applications for centralised marketing authorisations submitted after that date. See separate EMA press releases for further information.
For more details, go to: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2014/10/news_detail_002183.jsp&mid=WC0b01ac058004d5c1