The UK has become the first country in the world to introduce a framework for the regulation of medicines manufactured at or close to the place where is receiving care. 

New regulations laid in Parliament on 21 October mean that products with a very short shelf life, and highly personalised medicines such as gene therapy, can more easily be made in or near a hospital setting and reach patients who need them safely and quickly.

The regulations also allow for manufacture of innovative medicines in small, portable units that can be set up close to patients who may be too sick to travel or where rapid medicine availability is best served.

“This totally new framework, the first of its kind in the world, makes it possible to safely manufacture breakthrough medicines closer to where care is delivered and increases the attractiveness of the UK as a destination to market new life-saving medicines,” said Ian Rees, point of care lead at the MHRA.

The legislation proposes a six-month implementation period once Parliamentary processes have been concluded. This regulation could, therefore, become law in Summer 2025.

The MHRA is developing supporting guidance and says it will engage with industry, academia and healthcare institutions to ensure that the necessary interpretation and procedural support is in place to support the new regulations.

The Statutory Instrument amends the Human Medicines Regulations 2012 (SI 2012/1916) and the Medicines for Human Use (Clinical Trials) Regulations 2004 (SI  2014/1031) to provide a new regulatory framework for medicines manufactured at the point of care, and also for modular manufacturing, where products are manufactured in modular, relocatable units.