Life sciences regulatory & compliance partner Katherine Wang (Shanghai) co-authored an Asia-Pacific Biotech News article published on Dec.9. The article examines China’s Drug Administration Law that became effective on Dec. 1.
The authors explain that the new law encourages the development of innovative drugs with clinical value and provides pathways to expedite the approval timeline. The Chinese law also increases penalties for all kinds of illegal actions to deter misconduct by rigorous enforcement. It introduces a dual penalty system, subjecting both companies and individual responsible persons to sanctions.
The authors note that the shortened time to market will benefit R&D-based companies and incentivize generic manufacturers to transform. Frequent inspections and serious consequences for non-compliance will force companies to elevate quality control standards and more diligently perform their duties through the entire product life cycle.
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