Lin-Gang's Fast-Track Biomedical Data Transfer Rules

August 26, 2024 | BY

Susan Mok

New rules applicable to Shanghai's Lin-Gang New Area have been released. Wenpei Yu and Yunsi Hu of Lifeng Partners analyze their workings, how they fit into China's existing system of cross-border data transfer rules and why they are so significant for biomedical companies operating in the zone

Summary

  • China's current three-pillar cross-border data transfer regulatory regime is generally regarded as complicated
  • New rules issued by the Lin-Gang Special Area appears to amount to a fourth mechanism for cross-border data transfer
  • The new mechanism is applicable where the personal information of less than 100,000 individuals is processed
  • Completion times under the new mechanism could be as short as 15 working days; simplified documents and free supervision of filing are also attractive factors
  • Policy changes may impact the rules, but on balance the new system should benefit eligible companies

 

On May 16, 2024, the Lin-Gang Special Area of the China (Shanghai) Pilot Free Trade Zone ("Lin-gang") released its General Data List for the Cross-Border Transfer of Data in Biomedical Sector Scenarios (Trial Implementation) (the "New List") (临港新片区生物医药领域数据跨境场景化一般数据清单 （试行）). The New List covers data in five biomedical scenarios:

  • Clinical trial and R&D
  • PV and Medical Device AE Monitoring
  • Medical enquiries
  • Complaints
  • Vendor Management

 

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