Beijing is set to follow in the footsteps of Boao Lecheng with the release of the “Implementation Plan for Promoting the Construction of Rare Disease Drug Security Pilot Zone in Beijing (Trial) (draft proposal),” which concluded its public feedback period on August 13. The two-year policy initiative aims to establish a rare disease drug security pilot zone within the Beijing Tianzhu Comprehensive Bonded Zone, addressing the clinical medication needs for rare diseases.
The plan introduces a “white list” system for the security of rare disease drugs in the pilot zone, facilitating a temporary import convenience guarantee channel for urgently needed drugs through government guidance, bonded stocking by import enterprises, and streamlined customs clearance procedures. The goal is to develop a Beijing model characterized by multi-party collaboration, efficiency, convenience, closed-loop management, and traceability for the security of rare disease drugs. This includes a comprehensive “white list” system covering the temporary import, distribution, and use of urgently needed drugs for rare disease clinical practices (with separate lists for medical institutions, urgently needed drugs, and drug import enterprises). Once approved by the National Medical Products Administration, drugs on the “white list” will be bonded stocked by selected import enterprises, and designated medical institutions can import and use them multiple times within the approved quantity limits.
The “White List” of urgently needed drugs for rare diseases is compiled and released by the Beijing Municipal Medical Products Administration (BJMPA), based on the temporary import status of drugs approved by the National Medical Products Administration (NMPA). During the pilot phase, whitelisted drugs can be stored in the bonded area of the Beijing Tianzhu Comprehensive Bonded Zone, imported multiple times via a single customs clearance at Beijing Tianzhu Port, and utilized in approved medical institutions.
Medical institutions and drug import enterprises are legally required to assume risk responsibility for imported drugs. They must enter into agreements to define responsibilities and ensure drug quality.- Flcube.com
