ISSUING AUTHORITY:

National Medical Products Administration

DATE OF ISSUANCE:

August 31, 2026

EFFECTIVE DATE:

August 31, 2026

On August 31, 2026, the National Medical Products Administration (NMPA) issued the Announcement on Further Strengthening the Administration of Drug Information Traceability  (No. 85 of 2026), in accordance with the Drug Administration Law of the People's Republic of China and the Regulations for the Implementation of the Drug Administration Law of the People's Republic of China. It aims to further strengthen full-variety, full-chain informatized drug traceability management.

Marketing authorization holders, designated domestic responsible persons for overseas marketing authorization holders, drug manufacturers, drug distributors, drug-using entities, and traceability system operators shall assume their respective responsibilities. Marketing authorization holders, designated domestic responsible persons and drug manufacturers shall follow the principle of “one object, one code; trace both the drug and its code”. Marketing authorization holders and designated domestic responsible persons shall, in a timely, accurate and complete manner, file drug identifier information by logging in to the National Drug Traceability Collaborative Service Platform via the NMPA Government Service Portal, and complete multi-code association. For all product varieties in production, except active pharmaceutical ingredients, medical oxygen and medical institution preparations (with separate requirements to be formulated for traditional Chinese medicine decoction pieces), the relevant entities shall complete traceability-code assignment and activation, association of traceability codes for all levels of sales packaging units, and timely and accurate upload of traceability information before the products are placed on the market.

Non-compliance shall be strictly dealt with pursuant to the Drug Administration Law of the People's Republic of China, the Measures for the Supervision and Administration of Drug Operation and Use Quality, the Good Supply Practice for Pharmaceutical Products and other applicable laws and regulations.

Reference:

国家药监局关于进一步加强药品信息化追溯管理工作的公告（2026年第85号）