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UK MHRA Prepares To Roll-Out Decentralized Manufacturing Framework

New Guidelines Will Clarify Criteria To Enable Point Of Care And Modular Manufacturing

 
• By Vibha Sharma

The UK’s medicines regulator is pressing on with clarifying its expectations on decentralized manufacturing of medicines.

Gene Therapy for Cancer Treatment Concept Cancer therapy with T-cell and pipette
Decentralized manufacturing allows safe, personalized medicine production near patients (Shutterstock)
Key Takeaways
  • The UK medicines regulator is developing several guidelines to support the implementation of the new decentralized manufacturing framework for medicinal products that takes effect on 23 July 2025.
  • Among other things, the guidelines will elaborate on justifications that sponsors must provide and agree on with the medicines regulator before commencing point of care and modular manufacturing.
  • The guidelines are to be released in early summer and will be reviewed and updated regularly.

The Medicines and Healthcare products Regulatory Agency is developing a range of guidelines to support the UK’s new framework on decentralized manufacturing of medicinal products, which involves products being made...

The framework is expected to come into effect on 23 July 2025, and the guidelines are scheduled for released in early summer, the MHRA said in a statement on 19...

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