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UK MHRA Issues Landmark Infringement Notice To Celixir Over Serious Clinical Trial Violations

 
• By Eliza Slawther

The UK’s drug regulator said that a trial run by cell therapy firm Celixir “risked seriously jeopardizing the rights, safety and wellbeing of trial participants” after an inspection discovered expired product batches, unauthorized dosing and other serious breaches.

Compliance
• Source: Shutterstock

Celixir, a British regenerative medicine company formerly known as Cell Therapy Ltd, was handed a first-of-its-kind infringement notice by the UK’s drug regulator, the MHRA, after it failed to comply with a multitude of good clinical practice (GCP) regulations.

Key Takeaways 

  • An MHRA investigation of a clinical trial being run by Celixir revealed nine major and three serious findings in relation to good clinical practice principles.

The notice, published on 17 July, dated back to a 2020 GCP inspection of a trial sponsored by Celixir. Although...

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EMA Explores Supporting Drug Development For High Unmet Need Disorder Scleroderma

 
• By Neena Brizmohun

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EMA Nod For First MASH Drug Rezdiffra, Cell Therapy Zemcelpro And 11 Others

 
• By Eliza Slawther

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UK’s Decentralized Manufacturing Rules Designed To Allow For ‘Future Developments’

 
• By Eliza Slawther

The UK drug regulator acknowledges that technology will “move on” and, as such, has designed its decentralized manufacturing regulation to be as “enduring” as possible. Experts from the MHRA explain what products are covered by the new framework and how it has been future-proofed.

More from Geography

EMA Explores Supporting Drug Development For High Unmet Need Disorder Scleroderma

 
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