23
Accepted
Mandate MHRA to outline support for personalised medicine development within one year
Recommendation
The MHRA should also set out more broadly how current clinical trial structures can support the development and regulation of new personalised medicines. This should include an outline of what changes may be required to underpin this emerging and promising area. This should include early and regular engagement by regulators with the sector and a transformative approach to the safety testing and licencing of these exciting products. It should publish this within a year of this report being published.
Government Response Summary
The government commits to reviewing clinical trial legislation, with accompanying guidance to be published in 2024, and is establishing clinical trial acceleration networks to support innovation and new ways of delivering trials.
Paragraph Reference
102
Government Response
Accepted
Government Response
Accepted
HM Government
Accepted
MHRA is committed to supporting innovation, with early and regular engagement with the sector. Clinical trial legislation is in the process of being reviewed, with accompanying guidance to be published in 2024. Stakeholder engagement will be central to this process. The Lord O'Shaughnessy review into commercial clinical trials in the UK (8) was commissioned by the government to offer recommendations on how commercial clinical trials can help the life sciences sector unlock UK health, growth and investment opportunities. The government welcomes the recommendations from this review, including accelerating new and innovative ways to deliver trials. The government has committed to establish clinical trial acceleration networks, with funding to be used to deliver innovative, efficient and effective approaches for clinical trials.
Source
Report
First Report - The antimicrobial potential of bacteriophages
03 Jan 2024
HC 328
Addressee Bodies
Department for Science, Innovation and Technology
Timeline
Recommendation age
2.4 yrs
Report published
03 Jan 2024