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China's Draft Cell Therapy Guidelines Draws Concern From Industry

 
• By Brian Yang

New draft guidelines could potentially create parallel clinical pathways for cell and gene therapies in China, and industry executives are worried about different standards for such emerging treatments in a country with the highest number of ongoing cell therapy trials in the world.

CHINA CDE'S SENIOR REVIEWER HUANG HONGYUN AT CHINA RARE DISEASE SUMMIT LAST SEPTEMBER • Source: The Pink Sheet

China has now passed the US as the country with the highest number of clinical trials, but a recent new draft regulation from the Asian country’s top health regulator could open up a route to varying standards for the same type of products.

The draft, issued March 28 by China's ministry of health and the National Health Commission (NHC), officially outlined requirements and...

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• By Jung Won Shin

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• By Lisa Takagi

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Citeline Japan Awards 2025 - Enter Now!

 
• By Ian Haydock and Lisa Takagi

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