The UK is set to become the first country to introduce a regulatory framework for innovative medicines manufactured at the point of patient care, the Medicines and Healthcare products Regulatory Agency (MHRA) announced today. This new approach will facilitate the rapid production of short-shelf-life and highly personalized treatments directly in or near healthcare settings like hospitals and ambulances, enabling faster delivery to patients.
As per the press release, the MHRA’s new framework will support innovation in healthcare by removing regulatory barriers to point-of-care (POC) manufacturing, while ensuring these products meet the same safety, quality, and efficacy standards as conventional medicines. This follows a public consultation involving UK and international stakeholders, who emphasized the urgent need for such a framework for vital POC products.
The framework will benefit:
- Patients and carers: Enabling faster and more convenient access to new, personalized treatments.
- Healthcare professionals: Offering a wider range of treatment options and potentially improving patient adherence.
- Innovators: Providing clearer regulatory guidance to streamline product development.
Once implemented, the framework will cover all POC-manufactured products in the UK, including advanced therapies like cell and gene therapy, 3D-printed treatments, blood products, and medicinal gases.
To bring this framework into effect, new legislation amending the UK’s Human Medicines and Clinical Trials laws will be introduced in Parliament later this year. The MHRA is also working on developing accompanying guidance in collaboration with stakeholders and coordinating with other UK and international regulators to align regulatory processes.
Ian Rees, MHRA’s Point of Care manufacturing lead, expressed strong support for the initiative, saying, “These changes will drive tangible benefits for patients and enable easier access to a wider, more personalized range of treatments.”
Health Minister Will Quince praised the framework as a milestone, noting its potential to ease NHS pressures by reducing hospital stays and making treatments more accessible closer to home.
The results of the public consultation and the government’s response to POC regulation proposals are available for review.