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.
Explore More News
Launch of Online Training from ACDM
The Association for Clinical Data Management is delighted to announce the launch of Online . . .
Read More
ACDM 2019 Awards Finalists
The Association for Clinical Data Management are delighted to announce the finalists for . . .
Read More
Castor EDC to Sponsor ACDM19
The Association for Clinical Data Management (ACDM) are delighted to announce that Castor . . .
Read More
Danone Nutricia Research to Sponsor ACDM19
The Association for Clinical Data Management (ACDM) are delighted to announce that . . .
Read More
ACDM19 Conference Programme
The Association for Clinical Data Management is delighted to announce the Full Programme . . .
Read More
Record Number of Abstracts Submitted for ACDM19
The deadline for Abstracts for ACDM19 passed on the 30th September and the Association for . . .
Read More
Phastar Sponsor ACDM19
The Association for Clinical Data Management are delighted to announce that PHASTAR are . . .
Read More
Launch of Annual ACDM Awards
The Association for Clinical Data Management are delighted to announce the introduction of . . .
Read More
