Chinese Pharmacopoeia, 2025 Edition
China's legally binding pharmacopoeia — the 2025 Edition, promulgated jointly by the NMPA and the National Health Commission (Announcement No. 29 of 2025, issued 25 March 2025) and in force since 1 October 2025. Compiled by the Chinese Pharmacopoeia Commission, it carries 2,776 monographs (66 newly added) across traditional Chinese medicines, chemical drugs, biological products, and the general chapters and excipient standards that bind every drug marketed in China.
What this does not cover
stated in the document's own scope- Binding for drugs marketed in China; other markets apply their own compendia, and compliance with the USP or Ph. Eur. does not establish ChP compliance.
- Sets product standards; manufacturing practice is governed by China's GMP under the Drug Administration Law, administered by the NMPA and provincial authorities.
- The Chinese Pharmacopoeia Commission compiles; the NMPA and National Health Commission promulgate — the commission is the expert body, not the legal issuer.
Always verify against the current published text before relying on it for a submission or inspection.
Overview
The Chinese Pharmacopoeia (ChP) is China's legally binding drug compendium. The 2025 Edition — promulgated jointly by the National Medical Products Administration and the National Health Commission by Announcement No. 29 of 2025, issued 25 March 2025 and in force since 1 October 2025 — carries 2,776 monographs, 66 of them new, with more than 2,000 standards revised against the 2020 Edition. The compendium is compiled by the Chinese Pharmacopoeia Commission and spans four volumes: traditional Chinese medicines, chemical drugs, biological products, and the general notices, general chapters, and excipient standards that apply across all of them. Between publication and the effective date, marketing authorisation holders could elect either the old or the new standards; from 1 October 2025 the 2025 Edition governs.
Scope & applicability
Drugs marketed in China: ChP standards are mandatory under the Drug Administration Law, and marketing authorisation holders had a transition window from publication (25 March 2025) to the effective date (1 October 2025) to move to the new standards.
Legal basis & how it acquires force
Mandatory under China's Drug Administration Law: drugs marketed in China must comply with the current pharmacopoeia for the articles it covers. Each edition is promulgated jointly by the NMPA and the National Health Commission — Announcement No. 29 of 2025 for the current edition — on the basis of a draft compiled and approved by the Chinese Pharmacopoeia Commission, the standing expert body that operates under the NMPA's administration.
Document structure
| Part | Covers |
|---|---|
| Volume I — Traditional Chinese medicines | Monographs for TCM materials, decoction pieces, and preparations |
| Volume II — Chemical drugs | Monographs for chemical drug substances and preparations |
| Volume III — Biological products | Standards for vaccines, blood products, and other biologics |
| Volume IV — General requirements | General notices, general chapters and test methods, and pharmaceutical excipient standards |
Key requirements
- Articles covered by a ChP monograph comply with the 2025 Edition specification from 1 October 2025
- Testing per the ChP general chapters, interpreted through its general notices
- Registered standards align with the current pharmacopoeia where the ChP governs the article
Implementation tips
- Treat a ChP edition change as a change-control event across every China-registered product: monograph and general-chapter deltas ripple into registered specifications, and the transition window is the time to file the updates
Revision notes
The 2025 Edition (Announcement No. 29 of 2025) supersedes the 2020 Edition, revising over 2,000 standards; published 25 March 2025, effective 1 October 2025.
Where this control fails
live FDA enforcementLive FDA recalls SPEQ maps to this standard’s topics — a SPEQ interpretation, not an FDA classification.
International alignment
The ChP is the compendial layer of the same system whose GMP layer is China's Drug Administration Law GMP regime: the pharmacopoeia sets what marketed drugs must be, NMPA inspection enforces how they are made. The Chinese Pharmacopoeia Commission participates in international pharmacopoeial cooperation, and successive editions have converged general chapters toward international practice, but the ChP remains a national standard — products for China comply with it directly, not through USP or Ph. Eur. equivalence.
ChP 2025: frequently asked questions
Quick answers to common questions about ChP 2025.
When did the ChP 2025 Edition take effect?
It was issued by NMPA/National Health Commission Announcement No. 29 of 2025 on 25 March 2025 and came into force on 1 October 2025. During the transition window, holders could follow either the 2020 or the 2025 standards; from the effective date the 2025 Edition governs.
What changed in the 2025 Edition?
The edition carries 2,776 monographs including 66 new additions, with more than 2,000 standards revised against the 2020 Edition across its four volumes — traditional Chinese medicines, chemical drugs, biological products, and the general requirements volume.
Who writes the Chinese Pharmacopoeia?
The Chinese Pharmacopoeia Commission — the standing expert body operating under the NMPA — compiles and approves the draft; the NMPA and the National Health Commission then promulgate it jointly, which is what gives it legal force under the Drug Administration Law.
Does meeting the USP or Ph. Eur. satisfy the ChP?
No. The ChP is a national compendium binding in its own right: a product for the Chinese market must meet the ChP monograph and general-chapter requirements where they apply, and registered specifications must be aligned to the current edition.
This standard in practice
Recall domain is a SPEQ mapping of this standard’s topics, not an FDA classification.