lunes, 16 de enero de 2012

Clinical trials for medicines: UK clinical trial authorisation assessment performance

Clinical trials for medicines: UK clinical trial authorisation assessment performance



Clinical trials - Young scientistThese 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 authorisations.
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 data provided below details the number of applications assessed by MHRA, split by phase and commercial and non-commercial sponsors, with the exception of the GNA breakdown. Please note: the 2005 and 2006 data is only available as Phase I and Phase II/III/IV as the applications were not separated out any further at this time.
 The phase of application correlates with the phases described in The Medicines (Products for Human Use) (Fees) Regulations and not the phase described by the applicant on their application form.

No hay comentarios:

Publicar un comentario