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China Talks Up AI, Big Data, Cancer Care But Approval, Coverage Huddles Persist

 
• By Brian Yang

Leveraging the internet and big data to improve healthcare, regulatory efficiency and cancer treatment are among the priorities singled out by the Chinese Premier at the annual National People's Congress meeting. Some delegates say drug approval and coverage challenges remain, while industry observers point to commercial insurance as a solution to drive the specialty market such as cancer care.

Chinese flag
Chinese flags

Having the largest mobile internet population on earth and massive data, China is poised to upgrade its healthcare systems using the latest technology, from artificial intelligence to gene editing.

Premier Li Keqiang made it clear in his speech to the National People's Congress (NPC), held annually in Beijing, that...

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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.

China NMPA Lays Out Regulatory Priorities At DIA

 
• By Xu Hu

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• By Laura Helbling

Legislation prohibiting work with certain Chinese biopharma firms will be reintroduced soon, Democratic Sen. Gary Peters said. And it will not be the only bill tied to international biotech competition and security concerns that will be considered.

US FDA’s Expanded Surprise Foreign Inspections: Impact And Enforcement Hoops

 
• By Anju Ghangurde

As the US FDA expands unannounced foreign inspections building on pilots in India and China, experts expect higher scrutiny of overseas sites and perhaps even an industry shakeout in the longer term, though staffing and enforcement challenges could slow things down.

More from Asia

Australia Looks To Modernize Human Tissue Laws, Improving Access For Researchers

 
• By Eliza Slawther

Australia is reviewing its human tissue laws for the first time in almost 50 years, and is hoping to reduce barriers to access for scientific researchers, for instance by addressing issues with access to cell lines for developing drugs.

China NMPA Lays Out Regulatory Priorities At DIA

 
• By Xu Hu

At this year’s DIA China meeting, the national regulator updated its policy focus areas for this year, including clinical trial data protection and pilot projects to shorten IND approval times.

Japan Price Cuts For Epkinly and Lunsumio Following CEA

 
• By Lisa Takagi

Japan is cutting more drug reimbursement prices following cost effectiveness analysis and is applying the methodology to a new group of products including Wegovy and Leqembi.