Chinese Pharmacopoeia 2025 edition was officially released on March 25, 2025, and will replace the previous 2020 edition starting October 1, 2025. The National Medical Products Administration (NMPA) has issued supporting announcements to clarify the transition requirements. The updated Pharmacopoeia introduces major changes to the standards system, testing methods, traditional Chinese medicine quality control, and biological products regulation, including the adoption of the ICH Q4B international harmonization standard. These changes will significantly impact marketing authorization holders (MAHs), manufacturers, and overseas companies entering or operating in the Chinese market, requiring careful compliance planning.
Highlights
The Chinese Pharmacopoeia is typically updated every 5 years. Compared to the 2020 edition, the 2025 edition of the Chinese Pharmacopoeia (CP) consists of 5911 monographs, with 319 new additions, 3177 revisions, 10 rejections, and 6 reductions:
- Volume I of the CP includes 2711 monographs for traditional Chinese medicine (TCM), with 117 additions and 452 revisions.
- Volume II includes 2712 monographs for chemical drugs, with 117 additions and 2387 revisions.
- Volume III includes 153 monographs for biological products, with 20 additions and 126 revisions.
- Volume IV contains 361 general technical requirements, with 38 general requirements for preparations (35 revisions), 281 general testing methods and other general chapters (35 additions, 51 revisions), and 42 guidelines (12 additions, 12 revisions).
- The English version of the CP includes 335 monographs for pharmaceutical excipients, with 65 additions and 212 revisions.
One of the main features of the 2025 edition of the Pharmacopoeia is its focus on modern technologies and novel drug development approaches. This includes updated guidelines on biologics, traditional Chinese medicines, and complementary therapies, making it a more comprehensive and inclusive guide to the latest advancements in the field.
Transitional Implementation Precautions
1. Standard Applicability Rules
During the transition period for the 2025 Edition of the Chinese Pharmacopoeia (from March 25, 2025, the publication date, to October 1, 2025, the implementation date), enterprises may independently choose to follow either the original standards or the new pharmacopoeia standards based on their actual circumstances. However, the drug instructions must clearly indicate the version of the standards being followed to ensure regulatory transparency and traceability. From October 1, 2025, all newly marketed drugs must strictly comply with the requirements of the new version of the Pharmacopoeia, and drugs produced before this date can continue to circulate until the end of their validity period, without being subject to the new standards.
2. Registration Standards and Pharmacopoeia Coordination
MAHs must conduct a comprehensive evaluation of their drug registration standards before the official implementation of the new pharmacopoeia to ensure compatibility with the new requirements. If certain items or indicators in the registration standards are lower than those specified in the new pharmacopoeia, MAHs must promptly initiate standard upgrade work and complete changes through supplementary applications, record-filing, or reporting. For cases involving approval-type changes, such as formula adjustments or process optimizations, MAHs should submit supplementary applications before October 1, 2025, and continue to follow the original standards during the review period, switching to the new standards upon approval.
3. Implementation Choices for ICH Q4B Methods
The new pharmacopoeia aligns with international standards by incorporating the ICH Q4B guidance principles. Among these, 12 testing methods (e.g., sterility testing and bacterial endotoxin testing) are fully adopted via “direct harmonization,” requiring strict enterprise compliance. Another four methods (e.g., dissolution testing) are included via “parallel codification,” allowing new registration products to choose either the “first method” (original method) or “second method” (ICH method). For marketed products requiring method changes, adjustments must be completed through the record-filing process.
4. External Pollutant Control in Traditional Chinese Medicine
The new pharmacopoeia introduces additional safety standards for traditional Chinese medicine by adding limits for pesticide residues and heavy metals in 47 herbs.
Strategies for Overseas Manufacturers
In response to the new pharmacopoeia, overseas manufacturers are advised to focus on the following:
1. Immediate Compliance Assessment
Conduct a comprehensive comparison of existing product standards with new pharmacopoeia requirements, with a focus on key indicators such as testing methods and impurity limits. It is recommended to prioritize products with high market share or strategic significance in China.
2. Registration Document Enhancement
For products with standards below the new pharmacopoeia requirements, timely supplementary applications should be submitted through the local agent. Particular attention should be paid to the adoption strategy for ICH methods: new applications may directly select ICH methods, while marketed products requiring changes need to file.
3. Supply Chain Management Strengthening
Re-evaluate the compliance of raw material, excipient, and packaging material suppliers, and ensure supply agreements include new pharmacopoeia requirements. All technical documents must be prepared in complete Chinese versions and remain consistent with the original texts.
4. Special Requirements for Biological Products
Decide whether to retain the abnormal toxicity testing item based on risk assessment. Preventive biological products should not, in principle, be produced on the same line as therapeutic products. If co-production is necessary, a detailed risk assessment report must be provided.
Key Transitional Work Schedule
To ensure a smooth transition, overseas manufacturers are advised to advance work according to the following timeline:
- By the end of June 2025: Complete standard comparison and gap analysis for all marketed products.
- By the end of August 2025: Submit necessary supplementary applications or filing documents.
- By the end of September 2025: Complete production preparations for products compliant with the new standards.
- From October 1, 2025: Fully implement the new standards.
Special Note: For products manufactured before October 1, 2025, and compliant with the original standards, logistics timelines should be reasonably arranged to ensure customs clearance is completed before the transition period ends.
The implementation of the new pharmacopoeia is intended to enhance standards and drive an overall improvement in industry quality levels in China’s pharmaceutical market.This benefits international manufacturers who historically have had more rigorous quality systemsand compliance requirements. International manufacturers nevertheless should conduct gap analyses for all products, establish risk grading management mechanisms, systematically review the compatibility of existing testing systems with the new standards, and focus on validating critical methodologies.
Further Information
Here is the official NMPA announcements regarding the 2025 Edition of the Chinese Pharmacopoeia and its implementation details, including as appendices the 4 volumes of the Pharmacopoeia (Chinese language only). We expect an official English language version, similar to the 2020 ChP in the not too distant future.
Read about our previous article on the 2020 English ChP here:https://cisema.com/en/chinese-pharmacopoeia-2020-edition-official-english-translation/.
Reach out to Cisema if you have interest in any particular topics of the 2025 ChP or discover ourservices for manufacturers of pharmaceuticals, packaging and ingredients.
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