MHRA - Decentralised Manufacture Guidance Documents

11th June 2025

MHRA - Decentralised Manufacture Guidance Documents now available:

Decentralised manufacture: Clinical Trial Authorisation (CTA) and Good Clinical Practice (GCP)

Decentralised manufacture: UK Guideline on Good Manufacturing Practice (GMP)

Decentralised Manufacture: Labelling

Decentralised Manufacture: UK Guideline of Good Pharmacovigilance Practices

Decentralised Manufacture: Marketing Authorisation application

Decentralised manufacture: The designation step

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