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New UK Drug Applications At ‘Sustained Levels’ Post-Brexit

MHRA Vaunts ‘Exciting’ New Operating Model

 
• By Ian Schofield

The MHRA’s chief executive explains to the Pink Sheet how the agency will ensure the UK remains an attractive place to seek approval of new innovative drugs and build on the regulatory flexibilities introduced during the COVID-19 pandemic.

Closeup of mobile phone screen with logo lettering of UK MHRA agency, serum vials and syringe background - Image ID: 2H94BWR
The UK MHRA is undergoing a period of change • Source: Alamy

The UK Medicines and Healthcare products Regulatory Agency has painted a positive picture of its post-Brexit performance, saying that new drug applications have remained at “sustained levels” since the UK left the EU, and that the number of clinical trials is “buoyant.”

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French Bill Could Improve Clinical Research, But Further Action Is Required

 
• By Francesca Bruce

France’s simplification bill is a “first step” to improving the country’s clinical research environment, but more could be done to drive decentralized trials and simplify processes, says Leem, the French pharmaceutical industry association.

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New Carbon Monitoring Initiative Could Help Future Proof Clinical Research

 
• By Francesca Bruce

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More from Geography

EU Regulators Push For Better Support For Sponsors On Using Animal Study Alternatives

 
• By Eliza Slawther

The European Medicines Agency’s innovation network has recommended how the EU’s regulatory framework could be updated to support drug developers in using new approach methodologies, which are drug testing methods that reduce or replace animal studies.

New US FDA Roadmap Moves Closer To Animal Testing Alternatives

 
• By Bridget Silverman

New plan to encourage alternatives to animal testing seeks interagency cooperation to meet more aggressive targets for transformational change than the US FDA’s long-standing program.

HHS’ Kennedy Warns US FDA Staff Against ‘Agency Capture’ By Industry, Special Interests

 
• By Sue Sutter

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