Regulation and compliance
UpdatedUK medicines regulation briefing
A plain-English guide to how medicines are authorised, licensed and monitored in the UK, and what has changed since Brexit.
From £199
GDP and GMP compliance guide
What Good Distribution Practice and Good Manufacturing Practice expect of UK companies, and how inspections tend to go.
- Format
- PDF, approx. 50 pages
- Edition
- 2026 edition
- Delivery
- Download as soon as your payment arrives
This is a digital research report. It doesn't promote or supply any medicine, and nothing in it is medical, clinical, legal or investment advice.
What's included
- GMP and GDP explained, requirement by requirement
- Licensing: who needs what, and how to apply
- How inspections work and how to prepare
- Commonly reported deficiencies, from published inspection trends
- Falsified medicines safeguards and record-keeping
- Glossary and reference library
About this pack
Companies that make or distribute medicines work under detailed quality rules. This guide explains what Good Manufacturing Practice and Good Distribution Practice require, how licensing and inspection work, and the findings that regulators report most often.
It is written for quality, compliance and operations teams. It is general information, not legal or quality-assurance advice for your own site.
Scope and sources
UK legislation and MHRA guidance, with reference to EU GMP and GDP guidelines. Not legal or quality-assurance advice.
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