Chinese Pharmacopoeia: Understanding 42 Guidelines [English Version Available]
Chinese Pharmacopoeia is an official collection of drug standards, covering drug development, production, sale, utilization, supervision, and control in China. It is compiled by the Chinese Pharmacopoeia Commission. A new edition of Chinese Pharmacopoeia is regularly published every five years.
The latest edition of Chinese Pharmacopoeia was released on July 2, 2020, and took effect on Dec. 30, 2020. It includes 5,911 monographs on 2,711 traditional Chinese medicines, 2,712 chemical drugs, 153 biologics, and 335 pharmaceutical excipients.
Contents of Chinese Pharmacopoeia 2020
| Volume | Content | Number | |
| Volume I | Traditional Chinese medicine monographs | 2,711 | |
| Volume II | Chemical drug (including chemical APIs, also known as active pharmaceutical ingredients) monographs | 2,712 | |
| Volume III | Biologic product monographs | 153 | |
| Volume IV | General chapters | General requirements for preparations | 38 |
| Testing methods and other requirements | 281 | ||
| Guidelines | 42 | ||
| Pharmaceutical excipients monographs | 335 | ||
The Chinese Pharmacopoeia 2020 Edition also includes 361 general chapters, including 38 general requirements for preparations, 281 testing methods and other general chapters, and 42 guidelines.
42 Guidelines
| General Chapter No. | Guideline |
| 9001 | Guidelines for the Stability Testing of Drug Substances and Preparations |
| 9011 | Guidelines for In Vivo Bioavailability and Bioequivalence Studies on Drug Preparations |
| 9012 | Guidelines for Validation of Quantitative Analytical Methods for Biological Samples |
| 9013 | Guidelines for Sustained, Controlled and Delayed Release Preparations |
| 9014 | Guidelines for Microparticle Preparations |
| 9015 | Guidelines for Studies and Quality Control of Drug Polymorphism |
| 9099 | Guidelines for Analytical Method Verification |
| 9100 | Guidelines for Analytical Method Transfer |
| 9101 | Guidelines for Analytical Method Validation |
| 9102 | Guidelines for the Analysis of Impurities in Drugs |
| 9103 | Guidelines for Hygroscopicity Trials for Pharmaceuticals |
| 9104 | Guideline for Near-infrared (NIR) Spectrophotometry |
| 9105 | Guidelines for Bioactive Assays of Traditional Chinese Medicines |
| 9106 | Guidelines for Pharmaceutical Evaluation Based on Microarrays |
| 9107 | Guidelines for DNA Barcoding for the Molecular Identification of Traditional Chinese Medicine Ingredients |
| 9108 | Technical Guidelines for DNA Sequencing |
| 9109 | Guidelines for the Establishment of Standard Nucleic Acid Sequences |
| 9201 | Guidelines for the Validation of Alternative Microbial Detection Methods for Pharmaceuticals |
| 9202 | Guidelines for Microbial Limit Tests for Non-sterile Products |
| 9203 | Guidelines for Quality Management of Microbiology Laboratory for Pharmaceutical Products |
| 9204 | Guidelines for Microbial Identification |
| 9205 | Guidelines for Microbiological Monitoring and Control of Clean Laboratories for Pharmaceutical Products |
| 9206 | Guidelines for Validation of Isolator Systems for Use and Application in Sterility Testing |
| 9207 | Guidelines for Biological Indicators for Sterilization |
| 9208 | Guidelines for Resistance Performance Tests for Biological Indicators |
| 9251 | Guidelines for the Application of Bacterial Endotoxin Tests |
| 9301 | Guidelines for the Application of Safety Tests for Injections |
| 9302 | Guidelines for Establishing Limits for Harmful Residues of Traditional Chinese Medicines |
| 9303 | Guidelines for Determination of Pigments |
| 9304 | Guidelines for Determination of Aluminium (Al), Chromium (Cr), Iron (Fe) and Barium (Ba) in Traditional Chinese Medicines |
| 9305 | Guidelines for Determination of Mycotoxins in Traditional Chinese Medicines |
| 9306 | Guidelines for Genotoxic Impurity Control |
| 9401 | Guidelines for Validation of Bioactivity/Potency Testing Methods for Biological Products |
| 9402 | Guidelines for Stability Testing of Biological Products |
| 9501 | Guidelines for Quality Control of Positron Emission Tomographic Radiopharmaceutical Preparations |
| 9502 | Guidelines for Quality Control of Technetium [99mTc] Radiopharmaceuticals |
| 9601 | Guidelines for Research and Evaluation on Functionality-related Characteristics of Pharmaceutical Excipients |
| 9602 | Guidelines for Pharmaceutical Excipients of Animal Origin |
| 9603 | Guidelines for Quality Control of Premixed and Co-processed Pharmaceutical Excipients |
| 9621 | Guidelines for General Requirements for Drug Packaging Materials and Containers |
| 9622 | Guidelines for Pharmaceutical Glass Materials and Containers |
| 9901 | National Guidelines for Preparation of Pharmaceutical Standard Substances |
Reference Links
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If you need English translations of the guidelines or any other standards of APIs, excipients, and finished drug products in the Chinese Pharmacopoeia, or you have any questions about pharmaceutical regulatory compliance in China, please feel free to contact us.
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