The UK will be introducing a first-of-its-kind regulatory framework to make it easier to manufacture innovative medicines at the point of care (POC), the Medicines and Healthcare products Regulatory Agency (MHRA) said.
The framework will ensure that there are no regulatory barriers to innovative manufacturing and that these products have the same assurances of safety, quality and effectiveness as those made via conventional routes.
Currently, the human medicines legislation is geared for products that can be manufactured at a very small number of sites and supplied globally.
POC products, however, may only have a shelf-life of minutes or need to be highly personalised, so have to be manufactured on demand when the patient is present.
The new framework will make it easier to manufacture these medicines at or near hospitals, giving patients easier access to a greater range of innovative treatments.
UK health minister Will Quince said: “Patients, carers and healthcare staff across the country will benefit from this landmark initiative that will give them quicker access to innovative and personalised treatments closer to home.”
The announcement follows a public consultation carried out by the MHRA, in which respondents highlighted the urgent need to establish a regulatory framework for POC products.
The framework will apply to all POC products manufactured in the UK, including a range of advanced therapy medicinal products, including cell therapy, gene therapy and tissue engineered products.
In order to implement the new measures, legislation is being developed to amend the UK’s human medicines and clinical trials legislation and will be brought to Parliament later this year.
The MHRA said it will also begin to develop guidance, together with stakeholders, to accompany the new framework.
Ian Rees, MHRA POC manufacturing lead, said: “When implemented, these changes will drive tangible benefits for patients, with visible differences at the product innovation stage right up to the point of care, which will allow easier access to a greater and more personalised range of treatments for those in need.
“The accompanying guidance for the legislation will be absolutely critical for its implementation and interpretation, and we will ensure that there is effective engagement and dialogue with stakeholders to make this exciting framework a reality for people across the UK.”