MHRA performance data for assessment of clinical trials and established medicines
MHRA performance metrics for clinical trials and established medicines assessment
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To help improve the predictability of decision making in applications for clinical trials, marketing authorisations and variations to existing approvals, we are publishing routine updates to performance data for the assessment of clinical trials and established medicines, within 15 days of the end of each month. We previously published clinical trials information quarterly. We are also implementing several activities across the following areas.
1. Increased capacity by recruiting and training new staff
We have successfully recruited new assessors and continue to prioritise ensuring resource gaps are minimised. Many have already joined and are undergoing training. In addition, we are supplementing this new assessor capacity with additional resource of appropriately experienced and qualified specialists, and investigating new ways to accelerate training and develop staff capability and expertise.
2. Reduced backlogs
We have established Task & Finish Groups of subject matter experts to help us to reduce the number of delayed applications.
We have reallocated work and routinely evaluate applications and variations for their complexity. We are also reviewing activities to further improve the speed of assessment, such as the changes we have made to how licence holders should notify us of updates to the qualified person responsible for pharmacovigilance (QPPV) and the pharmacovigilance system master file (PSMF) details in product variations.
3. Improved communications and customer contact support
To help provide companies with more certainty about when their regulatory applications are going to be determined, our Customer Experience Centre is providing specific information to each applicant on when they can expect a regulatory decision on their current applications. We now offer the opportunity for companies with multiple applications to engage with us to reprioritise their applications, only if this does not have a detrimental impact on public health or product supply to the NHS.
We are committed to being transparent about our performance in reaching regulatory decisions on each type of fully compliant application and to this end we are publishing this data on our website each month.
Please review the most up-to-date performance metrics and timelines before contacting our Customer Experience Centre to check the status of your application(s).
Last updated 15 May 2023 + show all updates
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Added latest performance metrics for 'Assessment of Clinical Trial Authorisation Applications and Substantial Amendments' and 'Assessment of New Marketing Authorisation Applications and Variations'
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First published.