The UK is the first country to establish a dedicated regulatory framework for manufacturing innovative medicines at or near the point of patient care.

The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 has now been made law and will come into force on 23 July 2025.

This new legislation will facilitate the production of highly personalized treatments and medicines with extremely short shelf lives in hospital settings, ensuring faster and safer delivery to patients. It will also enable the use of small, portable manufacturing units, allowing innovative medicine production closer to patients who are too unwell to travel or have compromised immunity.

The legislation proposes a six-month implementation period. During this transition period, the MHRA is developing detailed, supporting guidance and will collaborate with industry, academia, and healthcare institutions to ensure that the necessary interpretation and procedural support is in place to support the implementation of the new regulations.

Our Regulatory Affairs team has a wealth of experience and will be following the developments of 
The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations as the MHRA provide more guidance. If you would like to discuss this regulatory framework or would like any advice, please get in touch and a member of our team will be happy to help.