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.

More from United Kingdom

Gene Therapy ‘Survival Of The Fittest’ – Why Companies Need To Understand Health Systems

 

Cell and gene therapy manufacturers must consider the practicalities of their product within the context of a health care system before it comes onto the market to be successful, experts from Novartis, AstraZeneca and England’s National Health Service say.

Branded Pharma And Generics Industries At Odds Over UK VPAG Framework

 

The UK branded drug industry is calling for adjustments to be made to the UK voluntary scheme framework for branded medicines, after the payment rate increased to 22.9% for 2025. Meanwhile, the generics industry says the scheme is functioning “as intended” and opposes any changes.

‘Hope And Scientific Spillover’ – Cross-Atlantic HTA Alliance To Focus On Novel Benefits

 

An initiative run by health technology appraisal (HTA) bodies in the US, Canada and England is looking at how non-traditional treatment benefits, such as the value of hope and scientific spillover, can inform appraisals and understanding of a product’s value.

UK MHRA Prepares To Roll-Out Decentralized Manufacturing Framework

 
• By 

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

More from Compliance

How To Leverage US FDA’s ‘Consistent With Labeling’ Guidance In DTC Ads

 
• By 

Sponsors should review longstanding agency concepts on consumer-friendly language and claims limitations, along with Office of Prescription Drug Promotion research and enforcement, when applying the 2018 CFL guidance to direct-to-consumer advertising, Sidley Austin’s Cope says.

US FDA May Lose Some Autonomy Under Health Department’s General Counsel Reorg

 

Health and Human Services Secretary Robert F. Kennedy Jr. is moving FDA Chief Counsel Robert Foster to a new senior position as Chief Counsel for Food, Research, and Drugs at HHS. Hilary Perkins will become FDA chief counsel.

EU’s Critical Medicines Act: A Major Milestone Or Too Weak?

 

Newly proposed legislation for bolstering the EU’s drug manufacturing capacity and reducing its overreliance on foreign manufacturers includes a number of measures, such a requirement for EU countries to prioritize the security of supply over price when procuring drugs.