The European Commission presented this month a proposal for a new regulation on clinical trials. Clinical trials means that the new medicines are tested on humans. On the one hand, it gives patients access to most recent, most innovative treatments and helps business develop new medicines and improve the already authorised ones. On the other hand, it can bring about quite a risk, which means that it needs to be strictly regulated. The new European Regulation is supposed to replace the 'Clinical Trials Directive' of 2001 and simplify and speed up the authorisation and reporting procedures, while at the same time keep up the high standards for patients' safety and the reliability of data. The Directive of 2001 was differently transposed by various Member States which led to unfavourable regulatory framework and a decline by 25% in clinical trials between 2007 and 2011. (Fostering EU's attractiveness in clinical research: Commission proposes to revamp rules on trials with medicines)
