Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2024 amend the 2004 Regulations rather than replace them. Combined MHRA + HRA review via IRAS becomes the standard legal pathway (combined-review pilot 2018-2023 now embedded). Single IRAS submission with protocol, IB/IMPD, ICF, patient-facing materials, GCP qualifications, insurance/indemnity, transparency plan, diversity plan; parallel MHRA CTA + HRA REC review; combined decision within ~30 days standard. Risk-proportional categorisation — Type A (drugs/uses no higher risk than standard medical care, typically licensed drugs near label) operates notification scheme; Type B (moderate risk, most Phase II/III on licensed drugs, off-label, comparator-controlled) operates expedited review; Type C (higher risk, first-in-human, novel mechanism, ATMPs, paediatric, vulnerable populations) operates full review. Sponsor proposes type with justification; MHRA confirms or recategorises. Mandatory transparency — public registry registration (ISRCTN, ClinicalTrials.gov, EU CTIS, EudraCT or recognised list) within 28 days of authorisation; summary results publication on registry within 12 months of last patient last visit including primary/secondary outcomes, adverse events and paediatric lay summary. Mandatory diversity-and-inclusion — sponsor considers participant diversity (ethnicity, sex, age, comorbidity, geography, socioeconomic) relative to target patient population with documented rationale; HRA inclusive-design guidance on recruitment, language accessibility (Welsh where applicable), inclusive consent. Divergence from EU CTR 536/2014 (CTIS) — separate submission systems (IRAS vs CTIS), different timelines and risk language, no UK-EU mutual recognition. Dual UK/EU trials run parallel submissions with shared protocol and adapted ICFs. Aligns with MHRA Innovative Licensing and Access Pathway (ILAP) and International Recognition Procedure (IRP).

Regulatory anchors

Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2024
Medicines for Human Use (Clinical Trials) Regulations 2004
ICH E6(R3) GCP

Industries that live with this

Pharmaceutical Blood & Tissue Vet Pharma

How V5 handles it

Score your compliance gap — then download the validation pack.

A guided self-assessment walks you against the regulator clauses that apply to your industry. The validation pack — IQ/OQ/PQ scripts, traceability matrix, risk assessment, intended-use statement — generates from the same evidence so you can hand it to an auditor on day one.

Document control with hard kiosk-level training enforcement.

Versioned SOPs are only useful if operators are actually trained on the current version. V5 enforces it at the kiosk.

QMS — quality engineered into every action, not bolted on.

Because V5 owns the operator action, the QMS sees the data the second it’s captured — not at the end of the shift.

Audits that change the next batch.

Checklist apps stop at the PDF. V5 keeps going — a failed line opens a non-conformance, optionally a CAPA, optionally a lot hold, optionally a supplier scorecard hit, optionally a training reassignment. The loop closes itself.