FOI release

FoI about CTIMP and non-CTIMP categorisation

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 FOI2025/00319

Received 31 March 2025

Published 30 May 2025

Request

1. Before the MHRA outsourced the decisions about whether a scientific experiment on humans with drugs/substances/IMPs is a clinical trial (CTIMP) or not a clinical trial (non-CTIMP) to universities and other bodies, the MHRA used to make these decisions. For 30 of the most recent applications you received before the change in policy, could you please release a summary of the proposed study (e.g. abstract) and your decision on whether it was a CTIMP or a non-CTIMP. 2. How do you monitor the universities that make these decisions and ensure that they are correctly categorising studies as clinical trials, and non-CTIMPs? I'm especially interested to know how you ensure that universities are not unnecessarily, *over*-categorising studies as CTIMPs. 3. Would this hypothetical experiment be a CTIMP or a non-CTIMP: a well known, GMP-manufactured drug is given at a safe dose in a one-off dose, double-blind, placebo-controlled RCT experiment to patients with a mental health condition to study the effects of this drug on an experimental behavioural measure (i.e. not clinical or safety outcome) in the lab. 4. What requirements do you put on universities who now make these CTIMP/non-CTIMP decisions about their transparency of decision-making to researchers? Do you require them to publish previous decisions and how they came to them, if they are asked?

Response

see attached

Documents

• FOI2025_00319 redacted for publication.pdf (121.3 KB)

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