China’s National Medical Products Administration (NMPA) has drafted measures to grant market exclusivity to qualifying rare disease and pediatric drugs. During the exclusivity period, NMPA would not approve competing products of the same variety. A rare disease drug would qualify if it treats a condition on the National Health Commission’s Rare Disease Catalogue or another rare condition confirmed by expert review. It must also be the first effective treatment in China or offer significant clinical benefit over existing options. Innovative or originator rare disease drugs already sold abroad would receive seven years of exclusivity once approved in China. Improved new drugs would receive five years of exclusivity. The first generic or biosimilar of a rare disease drug marketed abroad would receive four years of exclusivity. In addition, rare disease drugmakers must commit to a stable supply, and the NMPA could revoke exclusivity if supply fails or during a public health emergency.
Pediatric drugs would receive two years of exclusivity for an innovative or originator product. Adding the first pediatric indication, dosage form, or strength in China would earn one year, supported by pediatric trials. Companies would request exclusivity with their registration application, and the Center for Drug Evaluation (CDE) would review both together. Each application could request only one type of exclusivity.
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.