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CONTACTWe will continue to strengthen innovation-driven development, will vigorously encourage the integration of production and research, strengthen and improve the five domains: new drugs, biological drugs, traditional Chinese medicine, generic drugs and APIs
The 2025 Edition of the Chinese Pharmacopoeia Takes Effect on October 1
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发布时间：2025-03-26
【概要描述】
On March 25, the National Medical Products Administration issued an announcement stating that the 2025 Edition of the Pharmacopoeia of the People’s Republic of China (hereinafter referred to as the “Chinese Pharmacopoeia”) has been reviewed and approved by the Executive Committee of the 12th Pharmacopoeia Commission and will come into effect on October 1, 2025.
On March 25, the National Medical Products Administration issued an announcement stating that the 2025 Edition of the Pharmacopoeia of the People’s Republic of China (hereinafter referred to as the “Chinese Pharmacopoeia”) has been reviewed and approved by the Executive Committee of the 12th Pharmacopoeia Commission and will come into effect on October 1, 2025.
According to the Drug Administration Law, pharmaceutical products shall comply with national drug standards. The Chinese Pharmacopoeia is an essential component of these national drug standards and serves as the statutory technical standard that all relevant entities— including those engaged in drug research and development, manufacturing (including import), distribution, use, and regulatory oversight— are required to follow.
The Chinese Pharmacopoeia primarily comprises the General Notes, Monographs, General Technical Requirements, and Guiding Principles. Effective from the date of implementation, all marketing authorization holders and manufacturers of marketed pharmaceutical products shall comply with the requirements set forth in this announcement and in the current edition of the Chinese Pharmacopoeia. Notably, the requirements specified in the Guiding Principles are recommended technical requirements.
Effective from the date of implementation, for any product originally included in previous editions of the Pharmacopoeia or in standards issued by the State Drug Administration or relevant authorities, if such product is now included in the current edition of the Chinese Pharmacopoeia, the corresponding provisions in the previous editions of the Pharmacopoeia and in the relevant standards issued by the State Drug Administration or relevant authorities shall be simultaneously repealed; for products not included in the current edition of the Chinese Pharmacopoeia, the provisions in the corresponding previous editions of the Pharmacopoeia and in the relevant standards issued by the State Drug Administration or relevant authorities shall remain in force, provided that they comply with the relevant general technical requirements set forth in the current edition of the Chinese Pharmacopoeia. For products whose inclusion has been revoked or cancelled following post-marketing evaluation, the corresponding provisions in the previous editions of the Pharmacopoeia and in the relevant standards issued by the State Drug Administration or relevant authorities shall be repealed.
For dosage forms and preparation methods of traditional Chinese medicines that are not included in the main text of this edition of the Chinese Pharmacopoeia, their quality standards shall be in accordance with the relevant requirements for the same item in this edition of the Chinese Pharmacopoeia, while the specifications and preparation method entries shall be governed by the original approval documents.
The National Pharmacopoeia Commission is responsible for organizing and coordinating the promotion, training, and technical guidance related to the current edition of the Chinese Pharmacopoeia, and has established a “Chinese Pharmacopoeia Implementation Column” on its official website to promptly address issues raised during implementation.
Reprinted from Xinhuanet.
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