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News Archive
MHRA Updates Guidance on Modifying Clinical Trial Approvals: Introduction of Route A and B Processes
10th October 2025The MHRA has updated its guidance on modifying clinical trial approvals, introducing Route A and B processes to streamline amendments.
MHRA Updates Guidance on Non-Investigational Medicinal Products in Clinical Trials
10th October 2025The MHRA has released updated guidance on the use of non-investigational medicinal products (NIMPs) in clinical trials, effective from 28th April 2026.
MHRA Updates Labelling Requirements for Investigational Medicinal Products (IMPs) in Clinical Trials
10th October 2025The MHRA has released updated guidance on labelling requirements for IMPs used in clinical trials, effective from 1st October 2025.
MHRA and US FDA Forge New Collaboration on Medical Technologies and AI
10th October 2025The UK and US regulators have strengthened their partnership to accelerate innovation, enhance patient safety, and reduce market access barriers for medical technologies and AI-driven healthcare solutions.
UK Clinical Trial Approval Times Halved with AI and Regulatory Reforms
10th October 2025The UK has reduced clinical trial approval times from 91 to 41 days, enhancing patient access to new treatments.
WHO Launches Global Clinical Trials Forum to Strengthen Research Infrastructure
10th October 2025On 7th October 2025, the World Health Organization (WHO) officially launched the Global Clinical Trials Forum (GCTF), a collaborative network aimed at enhancing clinical trial environments and infrastructure globally.
New Commission to Accelerate NHS Use of AI
26th September 2025The UK establishes a National Commission to expedite safe AI integration into the NHS.
FDA Issues Final Guidance on Computer Software Assurance for Production and Quality System Software
25th September 2025The FDA has released final guidance to streamline software assurance in medical device manufacturing.
GVP Regulatory News 2025
22nd September 2025Now Available
MHRA - Looking to Our Future: Reflections on Strategic Choices Ahead for the MHRA
17th September 2025The MHRA reflects on its future priorities to strengthen healthcare regulation and innovation.
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