Clinical Trials Guidance

The European Commission has published an update of the Pharmacovigilance guideline and the Algorithm "What is a clinical trial?". The pharmacovigilance guideline adds some clarity for non-commercial trials. The Commission version of the algorithm differs slightly from the algorithm available on the MHRA website. Where the classification of a trial is not clear as a result of these different versions, the MHRA should be consulted for further advice. The Commission documents are available at:

http://pharmacos.eudra.org/F2/pharmacos/new.htm