China's New RDP Regulations

China’s National Medical Products Administration (NMPA) has promulgated the Administrative Measures for Pharmaceutical Regulatory Data Protection (RDP Regulations) on May 15, 2026.  Similar to other jurisdictions, regulatory data protection (RDP) affords the exclusivity protection of certain undisclosed trial data and can delay the regulatory approval of generic drug applications purporting to rely on such data.

NMPA's notice (Notice No.47 of 2026) that promulgates the RDP Regulations allow fifteen (15) working days from the aforementioned date of promulgation to submit retroactive applications for eligible drug products being reviewed or approved by NMPA.  Missing the deadline might result in abandonment of the relevant RDP rights. 

Below is a summary table for selected eligible drug products and the corresponding periods of protection listed under the RDP Regulations.

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