FOI release

clinical trial protocols

Some or all of the information requested was not provided because we determined that the cost to do so would exceed the appropriate limit.

Case reference FOI2026/00327

Received 24 March 2026

Published 11 June 2026

Request

Hi, I would like to request the following information under the Freedom of Information Act. 1. How many times has the MHRA previously reassessed approved protocols since 1st January 2021? 2. With reference to your response to question 1, how many times has the MHRA reassessed approved protocols within 6 months of initial approval? 3. With reference to questions 1 and 2, how often was this on the basis of "representations" rather than new emerging scientific evidence? 4. With reference to this letter recently published here: https://assets.publishing.service.gov.uk/media/6998b06d047739fe61889efb/Sponsor-letter110226.pdf, could you clarify what is meant by the term "representations"? 5. With reference to the same letter, could you clarify which individuals or organisations made these representations?

Response

See attached

Documents

• FOI2026_00327 (redacted).pdf (741.0 KB)

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