As of 1 March 2022 please direct all queries to the Clinical Trials Helpline: clintrialhelpline@mhra.gov.uk. The COVID-19 clinical trials unit mailbox will no longer be operational.

We have separate guidance as below:

Managing clinical trials during Coronavirus (COVID-19)

Prioritising COVID-19 assessments

The National Institute for Health Research (NIHR) are no longer accepting applications for studies to be designated as Urgent Public Health (UPH). The MHRA, however, continues to support COVID-19 trials with ongoing regulatory and scientific input. We also continue to provide full regulatory support to key UK policy driving clinical trials.

The MHRA has procedures for timely scientific advice, reviews and approvals and are ready to support manufacturers, researchers and other regulators. Having considered the change in public health need accompanying the vaccine roll out and the changes to the NIHR UPH prioritisation scheme, as well as the evolving situation in the UK, all further COVID-19 applications and meeting requests will be considered according to usual timelines.

Our usual scientific advice services are available and include the ability to arrange an informal 1 hour regulatory advice meeting to discuss any aspect of your clinical trial. We are also able to extend the discussion to wider aspects such as future marketing authorisation.

Submitting COVID-19 applications

From 1 January 2022, all new Clinical Trials of Investigational Medicinal Products (CTIMPs) applications are prepared, submitted and reviewed via the combined review service. This offers CTIMP applicants and sponsors a single application route and co-ordinated review by MHRA and the research ethics committee, leading to a single UK decision.

Applications for combined review are prepared and submitted in a new part of the Integrated Research Application System (IRAS). Further information on the process is available via the Health research Authority website.

We can be flexible and accommodating to Sponsors’ needs and if you have any specific requirements for your application then please contact us via the CTU Helpline (clintrialhelpline@mhra.gov.uk) or make your request clear in the submission covering letter.

If you want advice of any aspect of a clinical trial, call or email our Clinical Trials Unit on clintrialhelpline@mhra.gov.uk or 020 3080 6456.

You can also contact the HRA who can advise on expedited Ethics Committee opinion.

Naming your study

As requested by the WHO, please ensure that the WHO official acronym for the coronavirus disease (COVID-19) is entered in the title field of the trial registration data set (Annex 1 XML). This will facilitate finding and extracting clinical trials related to COVID-19 from public databases.

Participating in COVID-19 clinical trials

The MHRA as regulator will approve the eligibility criteria in a clinical trial protocol; however we do not get involved in deciding whether someone is eligible to participate in a clinical trial.

Please do not contact the MHRA for information about COVID-19 trials and whether or not you can take part. If you are interested in volunteering to take part in a trial we would recommend that you discuss this with your General Practitioner or other healthcare provider.

Any COVID-19 trials that are open for enrolment should be registered on a public site and you may wish to search these websites:

This is where you can access all of the information that is publicly available.

We have separate guidance on Managing clinical trials during Coronavirus (COVID-19).

MHRA guidance on coronavirus (COVID-19)

COVID-19 trial related activity

Prioritising COVID-19 assessments

Submitting COVID-19 applications

Naming your study

Participating in COVID-19 clinical trials

Clinical trials applications for Coronavirus (COVID-19)