RE: Reply from MHRA29 Jun 2023 17:51
Dear Caroline,
Thankyou for your correspondence of 21 March on behalf of constituent Mr Colin Rogers, about the medicines and Healthcare products Regulatory Agency (MHRA). Please accept my sincere apologies for the delay in replying
I appreciate Mr Rogers concerns
I understand from the MHRA that it did not delay approval of Sareum's clinical trial, but that it rejected the application. For reasons confidentiality, the MHRA is unable to provide details of the clinical trial authorisation (CTA) application to anyone other than the applicant. However, I can confirm that the MHRA's letter of 9 November clearly set out the reasons for the rejection.
Before rejecting a CTA application, the MHRA issues "grounds for no-acceptance (GNA), requesting the applicant provide further information support the trials authorisation. In the GNA letter, the MHRA provides contact details should the sponsor wish too seek further clarification on any GNA point raised
The MHRA recognises that companies need certainty about when their regulatory applications are going to be determined and will provide specific information to each applicant about when they can expect a regulatory decision on their current applications
The MHRA is aware that customers who have submitted initial applications and amendments to its clinical investigations and trials team have experience delays in some cases, and it understands how this unpredictability is affecting companies. To help improve the predicability of decision making for clinical trials, the MHRA has implemented several actions.These include staffing levels returning to normal, staff training, and introducing new processes to reduce the backlogs so that it makes regulatory decisions accordance with statutory timeframes for all new fully compliant clinical trial applications received from 1 September 2023.
The MHRA is also committed to being transparent about its performance in reaching regulatory decisions on each type of fully compliant application. It will publish this data on its website within 15 days after the end of each month ay, www.gov.uk/goverment/publications/mhra-performance-data-for-assesment-of-clinicl-trials-and-established-medicines.
I hope this is helpful
Signed, Will Quince , MP Minister of State
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