(Treffer aus pharmind, Nr. 09, Seite 1462 (2012))
EMA and EU Commission – Topical News / Proposal of a Regulation on Clinical Trials of the European Parliament and the Council, repealing the Clinical Trial Directive 2001/20/EC – Part I – Overview · Röhrig-Friese B · Rechtsanwaltskanzlei Röhrig-Friese, Betzdorf/Sieg (Germany)
Since 2001, the provisions on Good Clinical Practice are laid down in Directive 2001/20/EC (OJ No. L 121, 1.5.2001, p. 34 ff). Now a new proposal for a Regulation on clinical trials has been presented, which revises the legislative framework for clinical trials in Europe. In the assessment following the Commission Communication of 10 December 2008 on “Safe, Innovative and Accessible Medicines: a Renewed Vision for the Pharmaceutical Sector” the provisions of Directive 2001/20/EC had been identified as one of the most critical aspects of European pharmaceutical law, having led to a huge increase of costs for clinical trials for all ...