The 2025 edition of the Pharmacopoeia of the People's Republic of China (hereinafter referred to as the "Chinese Pharmacopoeia") has been promulgated by the State Food and Drug Administration and the National Health Commission Announcement No. 29 of 2025 and will be implemented from October 1, 2025. The relevant matters concerning the implementation of this edition of the Chinese Pharmacopoeia are hereby announced as follows:
1. According to the provisions of the Drug Administration Law, drugs shall comply with national drug standards. The Chinese Pharmacopoeia is an important part of the national drug standards, and is a statutory technical standard that should be followed by relevant units such as drug development, production (import), operation, use, supervision and management.
2. The Chinese Pharmacopoeia mainly includes examples, varieties and texts, general technical requirements and guidelines. From the date of implementation, all marketing authorization holders and drugs produced and marketed shall implement the relevant requirements of this announcement and this edition of the Chinese Pharmacopoeia. Among them, the relevant requirements of the guiding principles are the recommended technical requirements.
3. From the date of implementation, all varieties originally included in the previous editions of the Pharmacopoeia and the standards issued by the Bureau (Ministry) and the current edition of the Chinese Pharmacopoeia shall be abolished at the same time as the corresponding previous editions of the Pharmacopoeia and the standards issued by the Bureau (Ministry); If this edition of the Chinese Pharmacopoeia is not included, the corresponding previous editions of the Pharmacopoeia and the standards issued by the bureau (ministry) shall still be implemented, but shall meet the relevant general technical requirements of this edition of the Chinese Pharmacopoeia. For varieties that have been revoked or cancelled after post-marketing evaluation, the corresponding previous editions of the pharmacopoeia and the standards issued by the bureau (ministry) shall be abolished.