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MHRA ’Decentralised Manufacture Hub’

Date
March 20, 2025
Category

UK Regulations

Description

On 19 March 2025, the MHRA announced the establishment of a’ Decentralised manufacture hub’, see MHRA Decentralised manufacture hub.

This hub will eventually contain the new regulatory guidance that MHRA are currently drafting and which is expected to be published in early summer 2025. MHRA are in the process of developing decentralised manufacturing guidance on the following topics:

  • clinical trial authorisation (CTA) and good clinical practice (GCP) guidance
  • designation guidance
  • DM master file template
  • good manufacturing practice (GMP) guidance
  • guidance to help interpret the new regulation
  • labelling guidance
  • marketing authorisation application (MAA) guidance
  • pharmacovigilance (PV) MA guidance
  • PV early access to medicines scheme (EAMS) guidance
  • PV specials guidance

They will also develop joint guidance with other regulators such as the Human Tissue Authority, where necessary.