Guidance

Clinical trials applications for Coronavirus (COVID-19)

The MHRA is ready to prioritise and provide any assistance for clinical trials applications submitted for COVID-19

The clinical trials unit have set up a specific mailbox for COVID-19 related trial activity; Covid.clinicaltrials@mhra.gov.uk. This must be used instead of the previously used clinical trial helpline email. In this way COVID-19 related queries and questions will be monitored and responded to by a dedicated COVID-19 team as a priority. Examples of when to use this email include; COVID-19 related queries, request to arrange a COVID-19 specific informal advice meeting, requests for a pre-assessment, informal submission of a trial application, submission of supplementary data such as safety updates or any other information requested by the COVID-19 assessment team.

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.

The MHRA has procedures for rapid 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, the dedicated COVID team of assessors will provide the initial outcome of their assessment to Sponsors within 14 days. In addition, the team will be flexible and accommodating to Sponsors’ needs for a review in less than 14 days, as and where appropriate.

In addition to our usual scientific advice services we are also able 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. Meetings are arranged in an expedited timeframe (usually within 14 days).

To arrange an informal discussion please email Covid.clinicaltrials@mhra.gov.uk with a list of questions and outline of the proposal.

Submitting COVID-19 applications

Please submit any applications through the MHRA Submissions portal as usual. Please also inform the Clinical Trails Unit by emailing covid.clinicaltrials@mhra.gov.uk so we can track your application and expedite the review. We will then liaise closely with any applicants to ensure it’s managed as efficiently as possible.

For clinical trials for treatment or prevention of COVID-19 we are also able to provide an optional pre-assessment service. This allows 2-way continuous communication directly between the MHRA assessors and the trial Sponsor with direct feedback on a rolling review basis for any trial documentation. This can be prior to the formal submission. This service will only be provided to COVID-19 trials supporting government policy.

For more information or to submit documents for review please email our Clinical Trials Unit on Covid.clinicaltrials@mhra.gov.uk.

If you want advice of any aspect of a clinical trial, call or email our Clinical Trials Unit on Covid.clinicaltrials@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 does 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.

We strongly recommended that you access the resources listed below. If you have any additional questions related specifically to your own health, you should discuss these 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)

Published 19 March 2020
Last updated 3 August 2021 + show all updates
  1. Added new notes regarding support of trials.

  2. An update on the timelines and prioritisation of COVID-19 trial assessments

  3. Added a new section on COVID-19 trial related activity, and added a new email address to contact the clinical trials unit on.

  4. Added new information about how to arrange an informal regulatory advice meeting, an optional pre-assessment service for COVID-19 clinical trials and the average time for approving COVID-19 initial applications.

  5. First published.