The National Medical Products Administration ("NMPA") has recently issued the Announcement on Matters concerning Current Supervision and Administration of Drug Distribution (the "Announcement").
The Announcement states that after the effectiveness of the recently revised Drug Administration Law and before the promulgation of relevant supporting departmental rules, the Administrative Measures for Pharmaceutical Trading Licenses and the Measures for the Supervision and Administration of Drug Distribution will remain effective, and in the case of any discrepancy between the provisions thereof and the Drug Administration Law, the Drug Administration Law shall prevail. Meanwhile, the Announcement sets forth clear requirements on applications filed by newly established drug distributors for pharmaceutical trading licenses and applications filed by existing drug distributors for the replacement of their pharmaceutical trading licenses. The Announcement also clarifies that drug marketing authorization holders, drug manufacturers, drug distributors, and entities of drug use shall, in accordance with the Guiding Opinions of the National Medical Products Administration on the Building of Information-based Drug Traceability Systems and the uniform standards and specifications formulated by the NMPA, proactively institute an information-based drug traceability system, and in line with the subsequent work arrangements made by the NMPA, fulfill the whole-process traceability by category and in phases.