Compliance News: A blog on regulatory compliance and quality assurance topics, including current Good Manufacturing Practice (GMP), Good Clinical Practice (GCP) and Good Laboratory Practice (GLP).
30 May 2014
New Clinical Trials Regulation EU No. 536/2014 on Clinical Trials with Medicinal Products for Human Use
Regulation (EU) No 536/2014 published on 16 April 2014 by the European Parliament and the Council of the European Union on clinical trials on medicinal products for human use. This regulation will repeal Directive 2001/20/EC.