China Cuts Drug Approval Timelines, Sets Tough Penalties On Individuals Violating R&D Or Safety Rules
Newly released registration proposals signal the Chinese regulator’s intent to foster an environment that is conductive to innovation. Expedited new drug approvals alongside strict control over quality are key elements of these proposals.
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China Proposes Norms For Conditional Approval, Compassionate Use
Two new proposals by the China FDA will likely accelerate regulatory approvals of novel treatments for life-threatening and rare conditions in the country. By allowing foreign study data, these proposed norms are expected to prompt international drug makers to engage with local regulators early in their global new drug development process.
China Further Tightens Oversight Of Human Genetic Research
Although the latest implementing details classify many aspects of human genetic resource handling and transfer, foreign entities are severely restricted from developing gene and gene-editing therapies in China. Legal experts say the changes combined with data transfer and recent cybersecurity legislation pose additional challenges to life science companies operating in the country.
Falling At The Start Line: Chinese Firms Face Multiple Commercial Challenges Beyond Price, Coverage
Sales of a global first-in-class dermatology drug that gained its first approval in China are falling well behind those of its overseas counterpart. Brian Yang takes a deeper look into the multiple underlying factors determining success in the world's second-largest pharma market beyond pricing and reimbursement coverage, including complex hospital entry, dual channels and competition considerations.