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Bring Them On: 40 Orphan, Cancer Drugs Set For Priority Review In China

 
• By Brian Yang

New treatments for spinal muscular atrophy, glioblastoma, Gaucher's disease and others could be soon be hitting the China market following the awarding of priority reviews to a large list of novel therapies.

priority button
China Finalizes Priority Reviews For 40 Foreign Drugs • Source: Shutterstock

China’s regulators have just released the finalized list of foreign novel drugs that are slated for priority reviews due to urgent clinical need. Out of the 48 listed products, eight have already been approved recently and the remaining 40 should see new drug application (NDA) filings soon, noted the National Medical Products Administration (NMPA).

Upon the submissions, the administration’s Center for Drug Evaluation (CDE) will set up a special process to speed up reviews...

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Expedited Reviews For China-Originated Drugs Shift Back Home

 
• By Xu Hu

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.

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To Compete With China, US FDA Must Deregulate Early Gene Therapy Studies, CAR-T Inventor Says

 
• By Sarah Karlin-Smith

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.

More from Asia

Australia Targets Clinical Trial Reform, AI Use And Drug Shortages In 12-Month Plan

 
• By Eliza Slawther

Reforming clinical trial regulations, addressing the use of artificial intelligence, mitigating medicines shortages and strengthening ties with other drug regulators are key priorities for Australia’s Therapeutic Goods Administration over the next year.

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• By Lisa Takagi

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Beijing City Releases AI Action Plan Including Drug Regulation

 
• By Xu Hu

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