Regulation introducing a framework to enable the manufacture of highly personalised medicines and medicines with a very short shelf life, in or near the hospital setting, has been laid before Parliament.

The MHRA says the UK is the first country in the world to introduce a regulatory framework for this type of medicines manufacture.

The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2024 follow a consultation that showed a significant appetite from stakeholders for an innovative regulatory framework to enable novel approaches to manufacturing.

The new regulations contain a six-month implementation period to ensure that relevant parties have time to adapt to the changes, so could become effective in Summer 2025. 

The Statutory Instrument aims to relieve pressures on hospitals by enabling the development and manufacture of innovative and personalised products where it is most appropriate for the patient. It is also expected to assist in the expansion of 'hospital at home' services using virtual wards.

The Minister for Secondary Care, Karin Smyth, told Parliament that the regulations would allow treatments to be moved closer to the patient, perhaps even in the patient’s own home. She gave cell or gene therapies, 3D-printed medicines, or treatments derived from a patient’s own blood as examples of treatments the new regime is intended to cover.

Many of the medicines intended be covered by the new regime have a shelf-life of minutes or will require the patient to be present when they are manufactured, which currently makes it difficult to deliver the products to the patients that need them. 

The MHRA said its focus has been ensuring that its regulations are proportionate, flexible, and adaptable in order to increase the attractiveness of the UK as a market for new medicines. The MHRA will publish guidance to support implementation and will consult with industry, academia and healthcare institutions to ensure that sufficient support is in place ahead of the new regime's implementation. 

Please contact our Healthcare team if you have any questions.

This article was written by Rory Trust and Matthew Pegler.