UK Clinical Trial Authorization Assessment Performance
News Jun 18, 2008
From 1 November 2007, letters from the MHRA relating to clinical trial submissions will not be signed. The wording and format of letters from the MHRA relating to clinical trial submissions will also be modified from this date. This is in line with MHRA policy.
These measures of performance are intended to provide guidance to clinical trial sponsors on performance in terms of determination (acceptance, grounds for non-acceptance) for applications for clinical trial authorizations. The charts will be updated monthly to present performance over the current business year (April to March).
Historical data from implementation of the Clinical Trials Directive (1 May 2004) are also provided. As these data accumulate, the presentation will be on a five year rolling basis.
The historical data provide information on healthy volunteer and patient trials in terms of number of applications and average time to determination. The current year provides data on healthy volunteer and patient trials and, in addition, information for first time in man studies.