The Shanghai Municipal Commission of Commerce, in collaboration with Shanghai Customs and the Shanghai Municipal Medical Products Administration, has released an updated version of the “Shanghai Municipal Biomedical R&D Items Import Pilot.” The revised program, effective from August 1, 2023, through July 31, 2025, aims to expedite the market entry process for goods on the white list by eliminating the need to fill out “Imported Drugs Customs Clearance Forms.”
Enhanced White List System for Biomedical R&D Imports
The white list system, initially implemented on August 1, 2021, was designed to be updated semi-annually. The 2.0 version introduces a monthly update cycle, which better aligns with the R&D project undertakings of companies and R&D institutions. Companies already on the white list are now exempt from submitting additional materials beyond import R&D item information when filing for imports. The pilot program also includes strict compliance measures: any violation by a pilot company results in the revocation of their status and a ban on filing within the pilot period. Companies involved in criminal offenses will be transferred to judicial authorities for legal proceedings.
White List Impact and Scope
Since the implementation of the system, three white lists have been released, covering 32 products, with the majority filed by Wuxi Apptec (HKG: 2359, SHA: 603259)/Wuxi Biologics (HKG: 2269). The items on the white list are permitted for R&D purposes in Shanghai only, ensuring that the pilot program supports local innovation while maintaining regulatory control.-Fineline Info & Tech
