ACDM News Item

Clinical Trials for Medicines – New Notification Scheme

Date: November 27, 2023

The MHRA have recently launched a new notification scheme, the first step in their overhaul of the clinical trials regulations

The notification scheme enables a more streamlined and risk-proportionate approach to processing Clinical Trial Authorisation for “initial” applications.

This new scheme only applies to Clinical Trial Authorisation applications for Phase 4 and certain Phase 3 clinical trials deemed to be of lower risk; it does not include Clinical Trial Authorisation applications for first in human (FIH), Phase 1 or Phase 2, or amendments at this time.

For more information, visit their website here.

You can also watch a video from the MHRA on their LinkedIn here, where Deputy Director of Clinical Investigations and Trials, Andrea Manfrin, explains which trials are eligible for the scheme and the criteria for the trials.

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