Medicines and Healthcare products Regulatory Agency
UK regulator; issues GxP guidance and the widely-cited data-integrity guidance for the post-Brexit UK market.
WHAT MHRA COVERS
The Medicines and Healthcare products Regulatory Agency regulates medicines, medical devices, and blood components for the UK under the Human Medicines Regulations 2012 and the Medical Devices Regulations 2002. Since the UK left the EU it operates as a standalone sovereign regulator with its own authorisation routes, while retaining substantial alignment with EU technical standards.
WHERE IT SITS INTERNATIONALLY
MHRA is an ICH member and a PIC/S participating authority, and has established recognition routes that rely on approvals from trusted regulators. Its GMP expectations remain closely aligned with EU GMP.
HOW ITS REQUIREMENTS BITE
MHRA runs its own inspectorate across GMP, GDP, GCP, GLP, and GPvP, and operates a risk-based inspection programme. Sites are graded by the severity of deficiencies found — critical, major, other — and serious findings can lead to suspension of a manufacturer’s or wholesale dealer’s licence. The agency also publishes its own influential guidance, most notably on data integrity.
WHAT MHRA PUBLISHES
- 01GXP Data Integrity Definitions and Guidance for Industry (2018) — widely used far beyond the UK
- 02The "Orange Guide" (Rules and Guidance for Pharmaceutical Manufacturers and Distributors)
- 03Drug and device safety alerts, and Field Safety Notices
- 04Inspectorate blog posts and deficiency-trend reports that signal current inspection focus
- 05Guidance on UK authorisation routes and the Northern Ireland arrangements
WHAT PRACTITIONERS GET WRONG
- ›MHRA’s 2018 data-integrity guidance is a de facto international reference, not a UK-only document.
- ›Post-Brexit, UK and EU requirements are aligned in substance but are legally separate — check both where you supply both.
- ›Northern Ireland follows distinct arrangements; do not assume a single UK-wide position.
- ›The MHRA inspectorate publishes its common deficiency themes — read them before an inspection, not after.
MHRA STANDARDS SPEQ DECODES · 2
DISCIPLINES IN MHRA’S REMIT
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