Clinical trials for medicines: good manufacturing practice and radiopharmaceutical investigational medicinal products
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Guidance on good manufacturing practice and the use of radiopharmaceutical investigational medicinal products in clinical trials.
Adapted edition
- Document type
- Reference Guide
- Format
- DOCX
- Pages
- 5
- Language
- English
- Version
- 1.0
- Updated
- 2026-09-16
- Category
- Safety & operations
- Licence
- Open Government Licence v3.0
Description
Guidance on good manufacturing practice and the use of radiopharmaceutical investigational medicinal products in clinical trials. Consult the original guidance for current legal and operational details.
Contents
- The Clinical Trials Regulations
- Good manufacturing practice (GMP) for investigational medicinal products (IMPs) used in clinical trials
- GMP definition
- Labelling requirements
- Controls and processes for radiopharmaceutical (RP) investigational medicinal products (IMPs) used in clinical trials
- Radiolabelling of diagnostic 'cold kit' IMPs
- Full manufacture and radiolabelling of diagnostic IMPs
- Labelling specifics for radiopharmaceutical (RP) investigational medicinal products (IMPs) used for diagnostic purposes
- Radiolabelling of therapeutic IMPs
Source and licence
Medicines and Healthcare products Regulatory Agency
AttributionMedicines and Healthcare products Regulatory Agency, ‘Clinical trials for medicines: good manufacturing practice and radiopharmaceutical investigational medicinal products’ (updated 28 April 2026), reused under the Open Government Licence v3.0.
ChangesNeutral text-only adaptation from the official GOV.UK Content API body: headings, paragraphs, ordered and unordered list items and clickable source-link destinations in an appendix preserved. Images, logos, page design, accessible-format request widgets and linked attachments excluded; normalised whitespace, invisible format marks and typography.
Version history
- v1.016/09/2026