China on the Move: Fine-Tuning the Life Sciences Regulatory and Compliance Landscape

Lexology December 8, 2023
Greenberg Traurig LLP

In China, recent technological advances and legislative and regulatory developments that attempt to balance risk mitigation and innovation continue to reshape the life sciences sector in terms of cross-border partnerships and domestic business operations.

This GT Advisory explores the following topics:

• New drug development activities are robust notwithstanding a temporary industry slowdown.
• The national drug regulatory authority has tightened regulation and oversight over the contract manufacturing activities of the marketing authorization holders (MAHs) in China. Local provincial-level authorities must conduct onsite inspections to determine whether the MAHs are qualified to outsource the drug manufacturing.
• Updating regulatory documents regarding human genetic resources (HGR) to clarify operational issues related to international collaborative research and the scope of regulated HGR samples. .
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