These new measures of performance are intended to provide guidance to medicines licence applicants on expected timings for various aspects of the licensing and licence variation process. They follow feedback from the medicines trade associations that they wished to see separate metrics for our performance when dealing with purely national (UK only) licence and variation applications.
The charts will be updated monthly and will eventually present a rolling 13 months of data from which applicants can estimate likely service times and trends for their applications. If you would like to receive an email notification when the charts are updated, please subscribe to our free email alerting service (see under 'Regulatory information - medicines' on the registration form):
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Guidance on the interpretation of licensing time-based performance measures
This guidance provides an explanation of what the performance charts in the table below are showing.
Net times
All reported times are Net times for the MHRA work. This means that they do not include any time periods during which the submission was back with the applicant to provide additional data or clarification in order to complete the validation, assessment or determination.
Statistical measures
The 50% measure (median) is the time taken to complete that task for 50% of those submission types. Likewise the 90% measure (90th percentile) is the time taken to complete that task for 90% of those submission types. These measures give a better idea of the dispersion (range) of individual values than an average and therefore a better guide to the expected timing for an individual case.
Data sources
The data is derived from the MHRA Sentinel workflow management system and checked against data from other sources such as the European procedures CTS tracking system.
Month-on-month changes and trends
Peaks and troughs result from the normal monthly or seasonal variability of the volumes and types of work handled by the MHRA. However movement in the same direction over three months or more might be considered a ‘trend’.
Metrics and target times
The primary purpose of the charts is to provide guidance to licence applicants on expected times when they might receive acknowledgement of its validation, questions on its scientific content or grant of the licence or variation. Further up-to-date information on the initial stages of application processing can also be obtained from the MHRA’s Regulatory Information Service on 020 3080 7400.
Target times for the assessment of certain types of licensing work are included in the MHRA Business Plan 2009/10
(290Kb).
Licensing time-based performance measures
These first four charts measure the type of work carried out in the Information Processing Unit on both ‘self-certified’ and ‘validated’ Type IA notifications and on Change of Ownership Applications. The times reported are net times from receipt of the submission.
Time-based performance measures - Information Processing Unit (21Kb)
These 12 charts measure the times taken for work carried out in the MHRA Licensing and VRMM assessment teams. For UK MA only applications we show the time taken (from receipt of a valid application) for the first assessor to start the assessment, for all allocated assessors to complete their assessment, and for determination (grant or refusal) of the application. Completion of assessment and determination times are also shown for a range of other work types where the UK acts as an Reference Member State (RMS) in Decentralised or Mutual Recognition procedures or as Concerned Member State (CMS) for new MA determinations.
Time-based performance measures - MHRA Licensing and VRMM assessment teams (97Kb)
