Freedom of Information request about what clinical trials have been submitted to MHRA for approval to proceed (FOI 21/306)
Published 7 May 2021
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Thank you for your email.
Regarding your request for “what clinical trials have been submitted to MHRA for approval to proceed”, unfortunately this information is commercially sensitive and exempt from release under Section 41 (information provided in confidence) and Section 43 (commercial interests) of the FOI Act.
Section 41 is an absolute exemption and no consideration of the public interest is required, except to state that we consider its disclosure to constitute an actionable breach of confidence.
Section 43 is a qualified exemption and a consideration of the public interest should be made. We have considered the public interest and cannot see any public interest argument that outweighs the commercial harm in providing competitors with the details of clinical trials that are currently being considered for approval by MHRA. Examples of public interest arguments would be a major public health risk, or a major procedural failure or irregularity.
Details of trials that have been approved (other than adult Phase 1 trials which are commercially confidential) can be found in public databases such as the Health Research Authority research summaries database Research summaries - Health Research Authority (hra.nhs.uk) or in public registries such as Home - ClinicalTrials.gov or EU Clinical Trials Register - Update
If you have a query about the information provided, please reply to this email
If you are dissatisfied with the handling of your request, you have the right to ask for an internal review. Internal review requests should be submitted within two months of the date you receive this response and addressed to: info@mhra.gov.uk
Due to the ongoing Covid-19 situation, we are not able to accept delivery of any documents or correspondence by post or courier to any of our offices
Please remember to quote the reference number above in any future communications.
If you were to remain dissatisfied with the outcome of the internal review, you would have the right to apply directly to the Information Commissioner for a decision. Please bear in mind that the Information Commissioner will not normally review our handling of your request unless you have first contacted us to conduct an internal review. The Information Commissioner can be contacted at:
Information Commissioner’s Office
Wycliffe House
Water Lane
Wilmslow
Cheshire
SK9 5AF
Yours sincerely
MHRA Customer Service Centre
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU Telephone 0203 080 6000