UK MHRA: Clinical trials for medicines: authorisation assessment performance
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This data sets out the number of applications assessed by MHRA, split by phase and commercial and non-commercial sponsors.
The data for ‘approved vs grounds for non-acceptance (GNA) after first review’ and ‘outcome after assessment’ is accurate up to 2 months before the reporting month.
For example, the data reported in December 2012 for effective dates in November 2012 is accurate up to October 2012. This allows a full 60 calendar days to elapse for applications which get GNA after first review, and get a clinical trial authorisation following review of the sponsor’s GNA response.
The phase of application matches with the phases described in The Medicines (Products for Human Use) (Fees) Regulations and not the phase described in the application form.
Data is also provided for substantial amendments, split by phase. Monthly data is determined by the date initial assessment was completed, and not the receipt date.
Posted on the UK MHRA website on 21 April 2015