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Clinical Trials Regulations
12 December 2024
Type
Written Ministerial Statement
Department
Department of Health and Social Care
TAGS
At a Glance
Issue Summary
The statement announces significant reforms to UK clinical trials regulation through the Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2024.
Action Requested
The legislation aims to streamline and modernise the regulatory framework, reducing administrative burdens while ensuring participant safety. It supports recommendations from the Lord O'Shaughnessy Review to enhance commercial attractiveness and patient access to innovative treatments.
Key Facts
- The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2024 have been laid before Parliament.
- Over 2,000 responses were received during a public consultation in January to March 2022.
- The reforms aim to strengthen the UK’s position as a global leader for innovative clinical trials.
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