Skip to main content
NSF Home

New MHRA Guidance on Decentralised Manufacturing

Date
June 17, 2025
Category

UK Regulations

Description

Ahead of the new UK Regulation SI 2025/87 becoming effective on 23 July 2025, the MHRA has today published the following new guidance documents on the Decentralised Manufacturing (DM) Hub, see Decentralised manufacture hub - GOV.UK:

  • Human medicines Modular Manufacture and Point of Care regulations 2025: Overview.
  • Decentralised Manufacture: The design step.
  • Decentralised Manufacture: Marketing Authorisation application.
  • Decentralised Manufacture: Clinical Trial Authorisation (CTA) and Good Clinical Practice (GCP).
  • Decentralised Manufacture: UK Guideline of Good Pharmacovigilance Practices.
  • Decentralised Manufacture: UK Guideline on Good Manufacturing Practice.
  • Decentralised Manufacture: Labelling.

The DM guidance texts supplement existing guidance documents and are therefore intended to be read and used in conjunction with these texts. For example, the GMP guidance are set out in the MHRA ‘Rules and Guidance for Pharmaceutical Manufacturers and Distributors’ (known as the Orange Guide), EudraLex Volume 4 and PIC/S GMP.