UK MHRA Prepares To Roll-Out Decentralized Manufacturing Framework

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

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)

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 at or close to a patient’s location for administration.

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