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UK MHRA's -Updated Guidance: How to Apply for Authorisation in the UK

Clinical trials for Medicines: Apply for Authorisation in the UK (18 July 2022)

This updated guidance will detail how to apply for a clinical trial including eligibility, phases, model IMPDs, costs, and how to make changes to your application.

To apply for authorisation, A sponsor of a clinical trial needs to be established in the UK or a country on an approved country list that would initially include EU/European Economic Area (EEA) countries. If this is not the case, then the sponsor must have a legal representative who is so established.

As of 1 January 2022, the Combined Review Service is 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.

CTIMP applications via combined review should be started and submitted using the new part of the Integrated Research Application System (IRAS).

From 1 January 2022 the Health Research Authority (HRA) will automatically register clinical trials with ISRCTN Registry as one of the steps to ensure research transparency. This will start with clinical trials of investigational medicinal products (CTIMPs) that are submitted through combined review in the new part of IRAS.

The initial combined review assessment will be completed within 30 days of being submitted. the outcome be:

  • acceptance of the request for a clinical trial authorisation

  • acceptance of the request for a clinical trial authorisation subject to conditions

  • grounds for non-acceptance of the request for a clinical trial authorisation

If we raise grounds for non-acceptance you will have the opportunity to respond, usually within 14 days; however, this may be extended on request.

CLICK this LINK to know more on how to apply for authorisation in the UK

Guidance on Safety Tests on Chemicals

Also, there was a recent update to "Guidance on Safety Tests on Chemicals" which updated its content on UK GLPMA Guidance on the content of QA Statement 2022 & UK GLPMA Study Reporting Guidance 2022.


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