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 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...
The proportion of China-originated drugs granted expedited reviews in China doubled in the first half of this year, Pharmaprojects data show, surpassing those receiving similar treatment in the US and likely driven by multiple factors.
Amid the wait for an action plan to apply AI tools to drug regulation at the national level in China, capital city Beijing has released its own vision of scenarios for the technology in the healthcare sector.
China has announced a raft of new measures to encourage innovative drug development across the product life cycle, including using insurance data to differentiate new therapies and applying commercial insurance to selected novel products.
FDA regulation was painted as an obstacle to US dominance in the cell and gene therapy space even as panelists at an agency event praised the Office of Therapeutic Products' track record under Nicole Verdun.
