MHRA publishes 'ambitious plan to reshape regulation for a new era'

The MHRA has set out ambitious plans to translate cutting-edge scientific and technological innovation into better health outcomes for patients in its 2030 Strategy.

(c) Steve A Johnson/Unsplash

(c) Steve A Johnson/Unsplash

The strategy sets out the MHRA's commitments in six key areas: leading real‑world evidence generation and regulation; delivering operational excellence; providing patient-centred regulation; tackling the trade in illegal medicines; supporting innovation in life sciences; and increasing efficiency through international collaboration.

MHRA chair, Professor Anthony Harnden said: ‘Our 2030 Strategy sets out our vision for how we will harness extraordinary scientific and technological advances to catalyse innovation in the life sciences and accelerate access to safe and effective treatments for patients.'

The strategy's commitments include enhancing access to real-world data from hospitals and genomics, and fast-tracking the scientific advice service from 90 days to 45 days.

Targets also include halving the initial assessment target for qualifying Phase 1 clinical trials to 14 days and making faster decisions on generic and biosimilar products.

Plans for patient centred regulation include the launch of a Women's Health Plan this year and closing health gaps between different ethnic groups.

In addition, the commitments include reducing regulatory barriers for UK start-ups and smaller companies with a targeted voucher scheme, developing a more flexible and risk‑proportionate regulatory framework for rare disease therapies and better connecting the UK's genomics capability with the NHS and MHRA.

The plans also include publication of an AI Medicines Development Action Plan in 2027 and establishing an MHRA Centre for AI and Digital Health.

 

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