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UK MHRA Guidance on: Manage your authorisation & Report Safety Issues

The update was, that one of the SUSAR reporting routes has been removed from the Suspected Unexpected Serious Adverse Reactions (SUSARs) section.

As of 1 January 2022 the combined review service, formerly known as Combined Ways of Working (CWoW), is now the way that all new Clinical Trials of Investigational Medicinal Products (CTIMPs) applications are prepared, submitted, and reviewed.

A combined review offers a single application route and coordinated review leading to a single UK decision for CTIMPs.

Only substantial amendments need to be submitted to the MHRA.

Changes count as a substantial amendment to your clinical trial authorisation if the amendment is likely to affect to a significant degree

(a) the safety or physical or mental integrity of the subjects of the trial,

(b) the scientific value of the trial,

(c) the conduct or management of the trial, or

(d) the quality or safety of any investigational medicinal product used in the trial.

Click this LINK to know more about the Guidance on Clinical trials for medicines to manage authorisation, and report safety issues.


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