A global view on point of care manufacturing regulations after the UK’s leap
The UK’s Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 discussed in last week’s post, flipped the regulatory lens from post-code to process. By creating two new licenses; one for fixed hospital suites and one for relocatable micro-factories, with a single control site supervising every node through a live quality-management master file, the MHRA has written the world’s first clear pathway for turning cell, gene and other ultra-short-shelf-life products from a centralized craft into a distributed service.
For developers, that means the last, failure-prone hours of a CAR-T or CRISPR-edited product can now happen meters from the patient instead of hundreds of miles away. It also means regulators will review data-integrity safeguards, remote batch-release protocols and digital twins with the same rigor they once reserved for stainless-steel reactors which raises the bar overall, but shortens the critical vein-to-vein time. In the sections that follow we set the UK’s new framework beside emerging approaches in the United States, Japan and China to see which markets are closest to matching the MHRA’s lead and to identify where gaps remain.
Bringing the factory to the patient: we’re tracking the rules that make it possible.
United States: a framework taking shape
Across the Atlantic the FDA is edging toward a similar destination through its CDER FRAME initiative. Since 2022 the Agency has floated discussion papers on Distributed Manufacturing and Point-of-Care Manufacturing of Drugs, held dedicated workshops and, in November 2023, published a stakeholder action plan. The timetable now includes three draft guidances, the first of which (addressing control-strategy verification under 21 CFR 211) landed in January 2025. The concept mirrors the UK model (central QMS, remotely located units) but, for now, manufacturers must patch together existing CGMP provisions and request case-by-case advice while FDA finalizes its rule book.
Japan: a decade of hospital manufacture, newly widened
Japan actually legalised bedside manufacture back in 2014. Under the Act on the Safety of Regenerative Medicine (ASRM) physicians can prepare autologous cells in registered in-hospital suites, regulated site by site, while the Pharmaceuticals and Medical Devices Act (PMD Act) governs commercial products. That twin-track system is now tightening: an ASRM amendment coming into force on 31 May 2025 pulls in vivo gene therapy into the highest-risk tier and demands stronger conflict-of-interest controls and data oversight by Certified Committees for Regenerative Medicine. Japan therefore offers a functioning clinical pathway without mandating the real-time, multi-site master-file structure that the MHRA requires.
China: a maturing dual-track experiment
China’s regulators split advanced-therapy oversight between the National Health Commission (NHC), which lets accredited hospitals run investigator-initiated cell-therapy trials, and the National Medical Products Administration (NMPA), which handles industry INDs and licences. Draft NHC rules piloted in 2021 were finalized in September 2024, standardizing digital supervision and ethics governance for hospital-run trials, while the NMPA continues to refine 2017 and 2021 technical guidelines for gene-modified cells . The model already enables bedside manufacture, but licenses remain site-specific and provincial, and there is no single, central control-site concept, leaving data harmonization and nationwide scalability as open questions.
What this signals
Taken together, these moves show convergence on a core idea: personalized therapies can be finished where the patient is, yet controlled as if they were still made in one building. The UK supplies the first full legal scaffold; the FDA is drafting its solution, Japan is extending an established hospital channel into gene therapy, and China is aligning its fast-growing hospital track with national standards.
For therapeutic innovators the lesson is clear: design digital-first quality systems that can stream data from dozens of small reactors, bake remote intervention into CMC plans, and pick an early pilot jurisdiction in London, Boston or Tokyo to prove the model.
For technology innovators, the engineers building closed, automated cell-processing suites, rapid sterility assays, inline analytics, electronic batch-record platforms and AI-powered deviation handling, the opportunity is just as immediate. Hospitals will invest in turnkey, compliance-by-design micro-factories that drop into existing real estate, streaming validated data back to a control site and that can be overseen, paused or released by a Qualified Person half a continent away. Vendors that can wrap hardware and software into a tamper-proof, cloud-native ecosystem, complete with digital twins, secure SOPs and encrypted audit trails will find the UK an unrivaled proving ground and a springboard for the FDA’s forthcoming guidance.
