China's National Medical Products Administration (NMPA) released draft regulations on March 19, 2025, to strengthen clinical trial data protection for new drugs. The proposal offers up to six years of data exclusivity, preventing generic drug makers from using this data without consent. For foreign drugs, the exclusivity adjusts based on the time between overseas approval and application in China.

The protections apply to innovative drugs (six years), improved new drugs, and first-approved generics (three years). Exclusivity covers only undisclosed trial data submitted during initial marketing authorization. Applicants must request protection when applying for marketing authorization. Protection ends if approval is revoked or waived.

These measures aim to foster innovation while balancing market competition. Public comments are open until May 18, 2025. Hong Kong's Intellectual Property Department (IPD) will update its e-filing system and introduce new Trade Marks, Patents, and Designs forms starting May 16, 2025.

Changes include requiring agents to confirm a local presence in Hong Kong and adding enhanced data fields for IP transactions. Transitional periods allow old and new forms to be used interchangeably until November 16, 2025.

The e-filing system will automatically update pending forms to the new format on May 16, reverting "Ready for Submission" forms to "Draft" status for additional information. Updated XSD schemata for B2B filings are available for download. These updates aim to improve compliance and maintain Hong Kong's leadership in IP management.

Source: Adrian WININGER, China IP Law Update