MHRA publishes data on time taken to assess clinical trial applications

The Medicines and Healthcare products Regulatory Agency (MHRA) has published data on the time taken to assess clinical trial applications and substantial amendments.

The information includes the number of applications assessed by the MHRA split by trial phase and commercial or non-commercial sponsors. There were a total of 597 commercial and 121 non-commercial trials assessed between April and December 2018. The document also shows the average time for review of substantial amendments, ranging from 10.4 to 13.3 days for Phase I trials and 25.7 to 29.6 for Phase III to IV trials.

The full document is available here.

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Published on 24. January 2019 in News, News UK