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New Regulations to Enable Drug Manufacture at Point of Care

The Medicines and Healthcare products Regulatory Agency (MHRA) today announced changes that will make it easier to manufacture innovative medicines at the point of care (POC). "This will mean that new medicines with very short shelf lives, and highly personalised medicines, can more easily be made in or near a hospital setting or ambulance and can get to the patients who need them much more quickly," the Agency said.

Innovational POC products are increasingly being manufactured for patients either within or very close to healthcare settings. The purpose of the new framework "is to support increased manufacture of POC products whilst ensuring these products attain the same assurance of safety, quality, and efficacy currently in place for more conventional medicinal products", the MHRA pledged.

Its aim was specifically to design a framework that would create and regulate "a step change" in the range of manufacturing options, to enable the supply and increase the availability of innovative new medicinal products to patients. This new manufacturing and supply system in the UK healthcare system will benefit patients that currently have no or few treatment options by improving the availability of innovative medicines.

Regulations Needed for 'Vital and Varied' Products

The announcement follows a public consultation carried out by the MHRA between August and September 2021 in which the 51 responders (35 organisational and 16 individual responses) with experience of POC therapeutics highlighted "the urgent need to establish a regulatory framework for these vital and varied products".  

The consultation preamble noted that: "Technology is enabling the creation of new types of medicinal product that have features such as very short shelf lives and which may be highly personalised, requiring them to be manufactured and supplied at the point of care (POC).

"Current products typically have a shelf life measured in years and are manufactured at large scale in a relatively small number of factory-based sites for global distribution. Medicines regulation is geared for and supports such features; however, POC products do not fit this 'standard model' of regulation where manufacture is in the hospital and supply to the patient is immediate."

Health Minister Will Quince said: "Patients, carers, and healthcare staff across the country will benefit from this landmark initiative, which will give them quicker access to innovative and personalised treatments closer to home.

"The UK is a world leader in medicines, and this work we are spearheading will break down unnecessary regulatory barriers and free up hospital beds, while easing pressure on the health service."

UK First in World to Regulate Innovative Products

The new tailored regulatory framework for POC manufacturing will be the first of its kind in the world, and makes the UK a trailblazer in regulating innovative products manufactured at the point where a patient receives care.

"The new framework will ensure there are no regulatory barriers to innovative manufacturing," said the MHRA. It will be based on and link into current regulatory systems for medicines approvals, clinical trials, evaluation of regulatory compliance at manufacturing sites, and safety monitoring.

At present, products manufactured at the POC are eligible for support through the MHRA's Innovative Licensing and Access Pathway (ILAP), which is in place to accelerate time to market and facilitate patient access to novel therapeutics such as new chemical entities, biological medicines, new indications, and repurposed medicines.

"Once implemented, this innovative framework will apply to all POC products manufactured in the UK." This includes a range of advanced therapy medicinal products, such as cell therapy, gene therapy, and tissue-engineered products, 3D printed products, blood products, and medicinal gasses.

The MHRA said that the establishment of a regulatory framework for POC products would bring a range of benefits to a range of interested parties. Patients and carers would benefit by having access to new and more personalised treatments "in a timely and more convenient manner, with the potential for less travel and time spent in hospitals". Healthcare professionals would be enabled to provide "a greater range and more effective treatment options" as well as to improve patients' adherence to those treatments. Innovators would profit from having the MHRA providing "clear regulatory expectations" as well as "enabling easier product development".

Work in Progress to Enable a 'Joined-up Approach'

Implementation of the new framework will require a new legal basis, and such is being developed as an amendment to the UK's Human Medicines and Clinical Trials legislation, which will be brought to Parliament later this year. The MHRA will also begin to develop guidance, in conjunction with stakeholders, to accompany the new framework, which will be issued in due course.

Work has already started on "a joined-up approach with other regulators within the UK and internationally to facilitate the development of equivalent regulatory processes" and will continue in earnest throughout this process.

Ian Rees, MHRA Point of Care manufacturing lead, said: "As a regulator that champions innovation, we are delighted that our stakeholders are overwhelmingly supportive of introducing a fit-for-purpose UK legislative framework for POC manufacturing.

"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."