Hao Haiping, member of the CPPCC National Committee and president of China Pharmaceutical University, proposes improving supporting regulations

　　Providing legal safeguards for the rollout of electronic drug package inserts

　　As a vehicle for comprehensively presenting information on drug efficacy and safety, drug package inserts are an important guidance tool for clinical medication.

　　Considering that paper drug package inserts are prone to problems such as being hard to read, easily lost, and not updated in a timely manner, Hao Haiping, member of the National Committee of the Chinese People's Political Consultative Conference (CPPCC) and president of China Pharmaceutical University, proposes that the use of electronic drug package inserts should be gradually promoted.

　　In 2023, the National Medical Products Administration issued the Pilot Work Plan for the Reform of Drug Package Inserts for Elderly-Friendly and Accessible Use and related guideline documents, piloting electronic drug package inserts and encouraging their provision in the form of barcodes or QR codes on drug packaging or paper inserts. However, Hao Haiping pointed out through analysis that China is still in the pilot stage of electronic drug package inserts, has yet to improve the regulatory system at the level of laws and regulations, lacks an authoritative and unified data platform, access method, and data standards, and still faces problems such as terminology in inserts being too technical, causing patients to "not understand" them.

　　In this regard, Hao Haiping proposes improving supporting regulations and implementation rules, revising the Provisions on the Administration of Drug Package Inserts and Labels, clearly defining the legal definition, presentation form, format requirements, and implementation path of electronic drug package inserts, establishing the legal effect of electronic inserts, and improving supporting documents such as technical guiding principles and technical standards, so as to provide legal safeguards for full implementation.

　　Given problems in the pilot work such as inconsistent platforms for uploading electronic inserts and diverse ways of obtaining them by scanning codes, Hao Haiping proposes that the drug regulatory department establish a unified and authoritative public platform for electronic drug package inserts, based on review and approval and insert change management information, to ensure authenticity and timeliness. In addition, data standards for electronic inserts should be improved and technical requirements unified.