On March 19, China’s NMPA promulgated the draft – Interim Implementation Regulations for Drug Trial Exclusivity – with feedback expected by May 18. A similar draft was implemented in 2019, but not put in place due to industry objections. Data exclusivity will include independently produced clinical trial data incorporated in a marketing authorization (MA) submission. Within the exclusivity period, drug competitors cannot access protected data without the MA’s approval. Exclusive data protection covers new biologics, new chemical drugs, improved biological and chemical drugs, and new drugs approved overseas but not yet in China. This new 2025 draft outlines a lower protection period than the original 2019 version. China’s CDE, a sub-group of the NMPA, will be the ultimate decision maker on exclusivity that will be included in the marketing authorization dossier and final drug approval.
For Innovative drugs, there will be a 6-year exclusive data protection timeframe starting from the first domestic approval. For innovative drugs already approved overseas but not yet in China, there will also be an exclusivity period of 6 years, but this protection period will be reduced depending on the time difference between the approval overseas and the drug approval in China. For improved new drugs, there will be a 3-year data protection period. Similarly, for improved drugs approved overseas first, the protection period will be 3 years less the time difference from the approval overseas to the approval in China. In short, the sooner an approved overseas drug is also approved in China, the longer the exclusivity period will be. These exclusivity periods encourage overseas drug manufacturers to start their trials and registration in China as soon as possible.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.