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MHRA - DSUR Submissions and Fees are Changing

16th April 2024

MHRA - DSUR Submissions and Fees are Changing 

The process for submitting Annual Safety Reports (ASRs) for Clinical Trials of Investigational Medicinal Products (CTIMP) to the MHRA is changing. From 01 June 2024, ASRs such as the Development Safety Update Report (DSUR) will not be considered valid unless you provide proof of payment of the DSUR Review Fee with your submission. To avoid late submissions and non-compliance with the requirements of Regulation 35 of SI 2004/1031 (as amended), please ensure you consider the guidance here and on our webpages.

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