Introduction
The Medicines and Healthcare products Regulatory Agency (MHRA) has announced that the UK will be the first country to introduce a tailored framework aimed at making the manufacture of innovative medicines easier at the point of care. This will hasten patient access as new medicines that are highly personalised or have short shelf lives can be easily made in hospital/ambulance settings.
The newly tailored framework will ensure that products that are innovative medicines have no regulatory barriers with the same safety, quality, and effectiveness assurances given to products undergoing the usual access process. The framework has been developed in response to a public consultation conducted by the MHRA which identified both UK and international individuals and organisations as highlighting the urgent need to establish a regulatory framework for these vital point of care products.
What are the benefits?
The benefits of such framework apply to a range of individuals – patients and carers would have access to personalised treatments more conveniently. Healthcare professionals would have a greater range of effective treatment options to choose from, and innovators would have clear regulatory expectations, aiding future product development. Ian Rees, MHRA Point of Care manufacturing lead, stated that: “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”.
Once established, this framework will apply to all UK manufactured point of care products, including a range of Advanced Therapy Medicinal Products. New legislation will be developed to amend the current Human Medicines and Clinical Trials legislation, and will be brought to parliament this year, and the MHRA will begin the development of new guidance.
Source:
UK to introduce first-of-its-kind framework to make it easier to manufacture innovative medicines at the point of care. MHRA. https://www.gov.uk/government/news/uk-to-introduce-first-of-its-kind-framework-to-make-it-easier-to-manufacture-innovative-medicines-at-the-point-of-care. Accessed January 25th 2023.