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Guidance for clinical trials that use Decentralised Manufactured Investigational Medicinal Products (IMPs).
Project Orbis is a programme to review and approve promising cancer drugs helping patients access treatments faster.
UK guideline on GMP for decentralised manufacturing, ensuring compliance with EU GMP principles for safe, quality medicinal products.
Guidance on labelling for medicinal products used in clinical trials.
Guidance for industry on flexible approaches to regulation we are taking during the COVID-19 outbreak.
How to apply for a clinical trial from 28 April 2026, including eligibility, documentation and registration in a public registry.
List of words and phrases that will cause a veterinary product to be medicinal by presentation either through use or contextual use.
Guidance on using non-investigational medicinal products in a clinical trial.
How a marketing authorisation holder should report a defect with a veterinary medicine.
Guidance for the veterinary pharmaceutical industry on the production of mock-ups for assessment.
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