Shanghai-based ShangPharma hopes to capitalize on a growing wave of outsourcing by biopharmaceutical developers looking to reduce costs and spread risk in the wake of an R&D productivity slump.
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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.
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.
A system of pre-regulatory review consultations for innovative drugs and devices in South Korea has contributed to the accelerated development of such products.
Newly introduced rules for streamlining drug registration in Vietnam are said to present both opportunities and challenges for stakeholders.
