What is happening and why?
The Medicines and Healthcare products Regulatory Agency (MHRA) is accountable for controlling all medications and medical devices in the UK, ensuring the utmost effectiveness and safety standards.
This responsibility lies on the shoulders of the UK Department of Health and Social Care’s executive agency. Recently, a point of care consultation was conducted by MHRA to obtain feedback on ways to assure product quality and facilitate patient accessibility.
Being attentive to what the respondents said, they remain devoted to providing aide through their ILAP pathway to those merchandise manufactured at point of care sites; ensuring more efficient results in terms of time to market as well as patient access.
Official Announcement by the UK Government:
The UK will be the first country to introduce a tailored framework for the regulation of innovative products manufactured at the point where a patient receives care, the Medicines and Healthcare products Regulatory Agency (MHRA) has announced today.
This will mean that new medicines with very short shelf lives and highly personalized 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 new framework will ensure there are no regulatory barriers to innovative manufacturing and that products made via such routes have the same assurances of safety, quality, and effectiveness as those for conventional medicinal products.
This follows a public consultation carried out by the MHRA which heard from a range of individuals and organizations across the UK and internationally. In describing their experience with Point of Care (POC) products, responders highlighted the urgent need to establish a regulatory framework for these vital and varied products.
The establishment of a regulatory framework for POC manufacturing will bring a range of benefits to:
- Patients and carers – by providing access to new and more personalized treatments in a timely and more convenient manner with the potential for less travel and time spent in hospitals.
- Healthcare professionals – by providing a greater range and more effective treatment options and improved patients’ adherence to those treatments.
- Innovators – by providing clear regulatory expectations and enabling easier product development.
Once implemented, this innovative framework will apply to all POC products manufactured in the UK, including 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.
Next steps in this Process
In order to implement this framework, new 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 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 Point of Care 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 personalized 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.
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 personalized 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.
View the full results of the public consultation and the government’s response to proposals for the regulation of medicines manufactured at the Point of Care.
Sources: THX News, The UK Government & Medicines and Healthcare products Regulatory Agency.
