Transforming manufacture of innovative medicines at the point of patient care

Changes to the UK's regulatory framework will facilitate the manufacture and delivery of medicines at or near the patient's bedside. This framework represents a move away from the traditional approach to medicines regulation, based on centralised manufacture and distribution. The aim is to increase access to innovative medicines, including advanced therapy medicinal products (ATMPs) such as novel cell and gene therapies, radiopharmaceuticals, 3D printed products, blood products, and medicinal gases.

The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2024 will change the regulatory frameworks for both clinical trials and medicinal products. Two new categories of medicines are set out: point of care (POC) medicines and modular manufacture (MM) medicines.

The update follows a 2021 consultation with stakeholders, which showed strong support for the changes, and places the UK at the forefront of innovative regulation for these product categories.

POC medicines

POC medicines are manufactured on demand in the presence of, or close to, the patient, rather than in a centralised manufacturing process. This approach is particularly relevant for ATMPs, which are often highly personalised and have short shelf lives. Other products that may be suitable for POC manufacturing include 3D-printed products, blood products, radiopharmaceuticals, and medicinal gases.

Modular manufacture

Modular manufacture is a middle ground between the centralised approach and POC manufacturing. It involves semi-permanent or permanent units that may be self-contained or partially dependent on a central manufacturing hub. These units can personalise medicines, such as precision cancer immunotherapies.

The MHRA's 2021 consultation considered whether additional regulation for modular manufacture was necessary, but the conclusion reached was that changes were appropriate.

Current model – centralised manufacture

In the UK, manufacturing or importing human medicines requires a site-specific manufacturing license from the MHRA. Manufacturers must be able to demonstrate compliance with Good Manufacturing Practice (GMP), including passing GMP inspections. However, this model is unsuitable for hospitals providing POC medicines, leaving them to be provided as unlicensed "specials" medicines, and so limiting their scalability.

Key concepts

The changes augment the existing regulatory landscape by introducing new forms of manufacturer's licenses: “manufacturer’s licence (POC)” and the “manufacturer’s licence (MM)”. Similarly, for investigational medicinal products for use in clinical trials, a “manufacturing authorisation (POC)” and “manufacturing authorisation (MM)” will be available. Detailed descriptions of the arrangements for manufacture or assembly of the product will be maintained in a master file (the “POC master file”, “MM master file”, “POC (IMP) master file”, or “MM (IMP) master file”, as applicable).

The relevant master file will need to be kept up to date by the holder of the manufacturer's licence or authorisation, and the holder will be required submit to the MHRA an annual update on all changes made to the master file.

A hub-and-spoke model will be available, with a control site listed in the manufacturer's license and individual modular units or POC sites specified in the master file.

Compliance with GMP will remain crucial, with existing guidelines for short shelf-life products like radiopharmaceuticals expected to remain relevant for POC medicines.

The changes will take effect in July 2025, and the MHRA will issue guidance to support users with putting the new systems into practice.

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