New draft rules outline market exclusivity provisions for orphan and pediatric drug development, along with mutual recognition of ethics reviews, in developments being seen as positive for the industry.
The Chinese government on 9 May issued proposals to amend the implementing rules of the existing national Drug Administration Law, the paramount legislation regulating the pharmaceutical industry in the country.
The changes are being perceived as providing new support and a renewed policy tailwind to Chinese drug makers, although the...
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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.
Japan looks set to press ahead with a reimbursement price cut for Eisai's Alzheimer's drug Leqembi following a cost-effectiveness review, despite differences with the company over methodology.
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.
