The U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) announced that it will introduce a new regulatory framework to make it easier to manufacture medicines at the point-of-care (POC). Expected to become U.K. law later in 2023, the regulations will cover manufacturing in a range of POC settings, including in relocatable units and even in the home.
“Current legislation—like all legislation—is geared for what’s prevalent, which is factory-based manufacturing,” explains Ian Rees, MHRA point-of-care manufacturing lead. “If you’re making ultra-short shelf-life products [for example], you can’t make them unless the patient is there.”
The regulatory framework was developed based the results of a public consultation in 2021. It aims to benefit the manufacturers of emerging highly personalized medicines, such as CAR-T cell therapies, as well as those with shelf lives measured in minutes or hours.
According to Rees, the U.K.’s current Human Medicines and Clinical Trials legislation asks companies to list their manufacturing premises on their marketing authorization.
Differential impact
Although this works for companies with a handful of large manufacturing sites worldwide, it is “enormous effort for nil gain” for companies adopting a home or modular manufacturing model, he says. A company manufacturing at home or in a mobile production unit would find themselves regularly updating their marketing authorization to remove or add manufacturing sites. Moreover, each new site would need to be inspected.
The new legislation “borrows [ideas] with pride” from allied areas of healthcare, such as blood transfusion, notes Rees, where treatments are sometimes offered in the community.
Companies will be expected to specify a “hub” or “control site” that offers training and develops Standard Operating Procedures (SOP). This site will be inspected, along with a representative sample of “spoke” manufacturing sites, to ensure compliance with regulations.
It will also specify the keeping of a document adapted from the established regulatory requirements for a Plasma Master File, called a POC Master File, which will cover aspects of product quality and manufacturing location.
According to Rees, the new legislation aims to complement existing legislation and guidance—rather than adding to or replacing it. “If you imagine the MHRA is your house, we’re not doing a Grand Designs on it—we’re putting an extension on it—because the house itself is perfectly fine,” he explains.
Rees hopes the new regulatory framework will give clarity and certainty, enabling more technological development and investment. He also hopes that the development of home-based manufacturing will improve clinical outcomes because patients with cystic fibrosis, diabetic foot ulcers, or other diseases will be keener to start treatment if they can do so at home.
Speaking to GEN about what he’d recommend to a company concerned about point-of-care manufacturing regulation in the U.K., he adds, “I have a simple message—engage early. Come and talk to us!”
