IRAS Help - Preparing & submitting applications

Help - Preparing & submitting applications - MHRA Medicines

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MHRA Medicines

Guidance on preparing an application to MHRA Medicines for a Clinical Trial Authorisation using IRAS

IMPORTANT: Clinical Trials of Investigational Medicinal Products (CTIMPs) and Combined trials of an investigational medicinal product and an investigational medical device (IMP/Device trials).

It is no longer possible for a new CTIMP or IMP/Device trial application to be made using this part of IRAS. If you have an existing CTIMP or IMP/Device trial project and have not yet submitted your application, you will no longer be able to do so here.

For CTIMP and IMP/Device Trial applications previously submitted in the standard part of IRAS, these will continue to be processed in the usual way.

If you are about to start a new CTIMP application:

Please use our guidance on the HRA website for instructions on how to apply for combined review . Researchers already using the combined review service should login to the new part of IRAS.

Please note: If your combined review application will involve either ionising radiation or an investigational medical device, you should also review our separate instructions in IRAS help.

If you have any queries related to applying for combined review, please contact cwow@hra.nhs.uk.

MHRA notification scheme:

You should check if your trial meets the criteria for the new notification scheme. If it does, follow the instructions on the MHRA website to register your interest. Trials eligible for the MHRA's scheme, may also be eligible for fast-track REC review service, and applications are submitted through combined review.

New clinical trial regulations:

On 28 April 2025, the UK Parliament and Northern Ireland Assembly approved the Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025. These new regulations introduce changes to the Medicines for Human Use (Clinical Trials) Regulations 2004 which currently govern the regulation of clinical trials involving investigational medicinal products (CTIMPs) in the UK. The updated legislation will come into force on 28 April 2026. For further information on the changes we recommend you access the dedicated guidance published on the MHRA and HRA website.

New Clinical Trials of an Investigational Medicinal Product (CTIMPs)

Clinical Trial authorisation (CTA) is required for any CTIMP to be conducted in the UK. All CTIMP applications must now be made using the combined review service. Please use our guidance on the HRA website for instructions on how to apply for combined review. Researchers already using the combined review service should login to the new part of IRAS.

Existing CTIMPs, that were initially submitted using the standard part of IRAS

For existing CTIMPs that were previously submitted using this part of IRAS, you will still be able to access your project in the system. This might be necessary, for example, when making an amendment that requires changes to the initial application. For further guidance on making amendments to an existing CTIMP prepared in this part of IRAS please refer to the relevant section on ‘Notifying amendments to MHRA Medicines’ on our help pages.

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Page updated 12 October 2023