Recently, the National Medical Products Administration (NMPA) has released the Announcement on Further Enhancing the Supervision and Management of Drug Distribution (the "Announcement"), effective from the date of its release.
The Announcement specifies that those applying to establish new drug wholesale enterprises must possess private warehouses commensurate with the varieties of drugs they intend to distribute and their distribution scale, and the warehouses should meet modern logistics requirements as stipulated by the drug regulatory authorities at or above the provincial level and be operated and managed by their own personnel. It also encourages newly established drug wholesale enterprises to integrate existing resources, improve industry concentration, and upgrade modern management practices. Additionally, the Announcement requires that those applying to establish new drug retail enterprises must be staffed with practicing pharmacists or other legally qualified pharmaceutical technicians in line with their distribution scale and drug varieties. Pharmaceutical retail enterprises intending to distribute blood products or cell therapy biologics must demonstrate quality assurance capabilities and product information traceability capabilities commensurate with the varieties they intend to distribute. Furthermore, the Announcement emphasizes that when the validity period of a drug distribution license expires and a pharmaceutical wholesale enterprise applies for renewed review and issuance of a license, it should generally meet the requirements outline in the Measures for the Supervision and Management of Drug Distribution and Use Quality.