Recent data reveals how many clinical trial authorisation (CTA) applications and substantial amendments the Medicines and Healthcare products Regulatory Agency (MHRA) received and assessed in the past year, including statistics for novel trial designs.
The Medicines and Healthcare products Regulatory Agency (MHRA) has provided data on its assessment of clinical trial authorisation (CTA) applications and substantial amendments for the period August 2022 to September 2023.
Part of the main data highlighted included the performance metrics for regulatory CTA applications. In August 2023, the MHRA assessed 116 clinical trial authorisation (CTA) applications, its presentation revealed. This approaches double the volume for the same month the previous year.
Time for assessment
In July 2023, the average times for MHRA assessment of clinical trial applications were 50.50 and 20.75 days, respectively for Phase I healthy volunteer trials. This was 118.92 and 17.80 days, respectively, for Phase I to IV patient trials.
Initial clinical trial authorisation applications were divided into ‘first review’ (time from receipt of valid application to initial opinion letter) and ‘second review’ (the time from receipt of rounds for non-acceptance (GNA) response to final opinion). According to MHRA, the average time for assessment of a substantial amendment was 94.67 days.
CTA applications and substantial amendments – volume received and assessed
The number of substantial amendments received and assessed between August 2022 and Jul/Aug 2023 were reported. In August 2022, the number of substantial amendments assessed was 370. In August 2023, this number was lower, at 231.
For initial CTA applications received in July 2023, the amount increased from 74 in July 2023, compared to 63 applications in June 2023. In July 2023, the MHRA assessed 38 initial clinical trial applications.
The amount of substantial amendments received increased in July 2023, from 385 to 436 amendments. Of these, 363 were assessed by MHRA.
In its presentation, the MHRA provided additional summary data relating to total applications assessed between 31 July and 1 September 2023. The number of initial clinical trial applications assessed by MHRA were 331. The MHRA assessed 854 substantial clinical trial amendments in this period.
Novel trial designs
Additionally, the MHRA revealed that between August 2022 and Jul/Aug 2023, it assessed a total of 11 initial clinical trial authorisation (CTA) applications for novel trial designs. For amendments in this period, the total was eight.
The MHRA stated that a full breakdown of data for August will be published within 15 working days of the month.
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