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.

Explore More News

Signant Health are ACDM22 Photography sponsors

The Association for Clinical Data Management are delighted to announce that Signant Health . . .

Anju Software is exhibiting at ACDM22

The Association for Clinical Data Management is delighted to announce that Anju Software . . .

SGS Health Science to sponsor ACDM Awards for the second year running

The Association for Clinical Data Management are delighted to announce that SGS Health . . .

ACDM Interactive

The ACDM would like to thank everyone involved with ACDM Interactive in Manchester. The . . .

nuvoteQ to be a Premier Sponsor of ACDM22

The Association for Clinical Data Management is delighted to announce that nuvoteQ are to . . .

IQVIA to be a Premier Sponsor of ACDM22

The Association for Clinical Data Management is delighted to announce that IQVIA are to be . . .

Anju Software to be a Premier Sponsor of ACDM22

The Association for Clinical Data Management is delighted to announce that Anju Software . . .

CORE to be Premier and Interactive Sponsor for ACDM22

The Association for Clinical Data Management is delighted to announce that CORE from the . . .

eClinical Solutions to be Premier and Communications & Social Media Sponsor for ACDM22

The Association for Clinical Data Management is delighted to announce that eClinical . . .

ACDM Annual General Meeting

The ACDM AGM will take place on Monday 6th September at the INNSIDE Manchester Hotel, . . .

Phastar announced as Premier & Conference Dinner Sponsor of ACDM22

The Association for Clinical Data Management is delighted to announce that Phastar are to . . .

New online training course – Risk Based Monitoring

The Association for Clinical Data Management is delighted to announce the launch of their . . .