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

Summary

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• 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

A wide scope of data across the whole biomedical sectoral ecosystem are included in the New List. According to Article 13 of the Lin-Gang Special Area of the China (Shanghai) Pilot Free Trade Zone, Measures for the Administration of Cross-Border Flow of Data by Category and Level (Trial Implementation). (中国（上海）自由贸易试验区临港新片区数据跨境流动分类分级管理办法（试行）) (the "Measures"), the listed data can be transferred provided that such data transfer activity has filed with the Lin-Gang Special Area Administration (临港新片区管委会) (the "Administration"). In other words, outbound transfer of general data in Lin-gang is subject to an ex-ante condition of obtaining a filling clearance. We will refer to this process as the "Lin-gang CBDT legal mechanism".