UK Statutory Instrument 2025 United Kingdom

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

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At a glance

Enforced by

MHRA

What's here

2 compliance obligations, 1 practical guide · 1 journey

Penalty landscape

1 of 2 obligations carry up to 2 years imprisonment. 1 has no criminal penalty — flagged in the list below.

Who this Act binds

Business-side actors with duties under this Act, ranked by how often they appear.

  • Any Person 1
  • Client 1

Step-by-step journeys using this legislation

Walkthroughs that take you from a real business situation to compliance.

Relevant guidance

Practical guides for businesses affected by this Act, ordered by how closely they engage with it.

Supporting — topic alignment

1 guides

Other Acts binding the same actors

For each actor bound by this Act, the other UK Acts that bind them most often. Useful for understanding the full compliance landscape facing each role.

Any Person also bound by 749 other Acts (top 5 shown)
Clients also bound by 30 other Acts (top 5 shown)

What this Act requires

Sections that create concrete duties on businesses or carry penalties. Procedural and definitional sections are folded into the “Browse other sections” expander at the bottom of each group. Click any section title to read the source text on legislation.gov.uk.

Part 1 — General

Browse 2 other sections in this Part — procedural / definitional / commencement

Part 2 — Amendment to Part 1 (Introductory Provisions)

Browse 3 other sections in this Part — procedural / definitional / commencement

Part 3 — Amendment to Part 2 (Ethics Committees)

Browse 4 other sections in this Part — procedural / definitional / commencement

Part 4 — Amendment to Part 3 (Authorisation for Clinical Trials and Ethics Committee Opinion)

Browse 7 other sections in this Part — procedural / definitional / commencement

Part 5 — Amendment to Part 4 (Good Clinical Practice and the Conduct of Clinical Trials)

Browse 6 other sections in this Part — procedural / definitional / commencement

Part 6 — Amendment to Part 5 (Pharmacovigilance)

Browse 3 other sections in this Part — procedural / definitional / commencement

Part 7 — Amendment to Part 6 (Manufacture and Importation of Investigational Medicinal Products)

Browse 4 other sections in this Part — procedural / definitional / commencement

Part 8 — Insertion of new Part 6A (Non-Investigational Medicinal and Non-Medicinal Products)

Browse 1 other section in this Part — procedural / definitional / commencement

Part 9 — Substitution of Part 7 (Labelling of Investigational Medicinal Products)

Browse 1 other section in this Part — procedural / definitional / commencement

Part 10 — Amendment to Part 8 (Enforcement and Related Provisions)

s.034

Amendment to regulation 49

2 years imprisonment
  • Supply non‑investigational medicinal product with non‑compliant labeling for a clinical trial Any Person
Browse 2 other sections in this Part — procedural / definitional / commencement

Part 11 — Amendment to Part 9 (Miscellaneous Provisions)

Browse 1 other section in this Part — procedural / definitional / commencement

Part 12 — Amendment to the Schedules

Browse 6 other sections in this Part — procedural / definitional / commencement

Part 13 — Consequential provisions

Browse 1 other section in this Part — procedural / definitional / commencement

Part 14 — Transitional provisions

Browse 2 other sections in this Part — procedural / definitional / commencement
Read the full Act on legislation.gov.uk (opens in a new tab)

Official guidance

Authoritative sources published by regulators or government explaining this legislation.

Enforcement and responsible bodies

The regulators that administer or enforce this legislation.

MHRA

Medicines and Healthcare products Regulatory Agency

Regulates medicines, medical devices, and blood components. Ensures safety, quality, and efficacy. Issues marketing authorisations.

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Browse legislation

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Regulators

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