EUCOPE’s Experts on Orphan Drugs Meet in Berlin

Experts on orphan drugs from the European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) met in Berlin on 7 May. BIO Deutschland also attended this meeting. Among the topics on the agenda were country updates on regulatory requirements in the field of rare diseases for the United Kingdom, Germany, Italy and Spain. The experts also discussed the European Medicines Agency’s (EMA) adaptive licensing concept, which aims to improve timely access for patients to innovative medicines. The EMA is currently looking for companies to explore and evaluate this new approach in a joint pilot project.  

In the adaptive licensing concept, the EMA is suggesting a licensing process that will provide selected patients groups with faster access to medicines. This would give patients for whom no alternative treatment is available access to medicines in development at an earlier stage than before. In return, the earlier licensing will be followed by an iterative process aimed at gathering further information and findings for the complete licensing process. BIO Deutschland has been a member of EUCOPE since June 2011.

Further information is available on the EMA website at www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2014/03/news_detail_002046.jsp&mid=WC0b01ac058004d5c1 or from the BIO Deutschland office.