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.
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
ACDM DMEG News: Regulatory Updates and Forthcoming Challenges for 2025
As 2024 draws to a close, the Regulatory Considerations Data Management Expert Group . . .
This website uses cookies to improve your experience while you navigate through the website. Out of these cookies, the cookies that are categorized as necessary are stored on your browser as they are as essential for the working of basic functionalities of the website. We also use third-party cookies that help us analyze and understand how you use this website. These cookies will be stored in your browser only with your consent. You also have the option to opt-out of these cookies. But opting out of some of these cookies may have an effect on your browsing experience.
Necessary cookies are absolutely essential for the website to function properly. This category only includes cookies that ensures basic functionalities and security features of the website. These cookies do not store any personal information.
