The UK Clinical Trial Regulations - indexed and consolidated

Incorporating The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025

This book contains The Medicines for Human Use (Clinical Trials) Regulations 2004, which are up to date with all changes known to be in force on or before 24 September 2025. This includes SI 2025 No. 87 (The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025), which came
into force on 23 July 2025.

In addition, SI 2025 No. 538 (The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025) has been incorporated into the text.

Changes resulting from The Human Medicines (Authorisation by Pharmacists and Supervision by Pharmacy Technicians) Order 2025 (SI 2025 No. 1249) have also been added.

The different sets of 2025 changes have been highlighted in colour for easy identification.

We have also compiled a key-word index so that you can find the relevant parts of the regulation more easily