Chinese Pharmacopoeia 2020 edition was translated into English and officially published by the Chinese Pharmacopoeia Commission (CPC) on March 14, 2023. The Chinese edition was released on July 2, 2020, and implemented from December 30, 2020, onwards. The document provides a detailed overview of the China quality standards and specifications for drugs and pharmaceutical products, making it an essential reference for both manufacturers and users of drugs around the world.
The Chinese Pharmacopoeia is typically updated every 5 years. Compared to the 2015 edition, the 2020 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 latest 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.
The 2020 Pharmacopoeia is designed to keep pace with the rapid changes in the pharmaceutical industry with a particular focus on innovation and evolution. Whether it is new production processes, the introduction of new drug categories or emerging drug delivery mechanisms, the Pharmacopoeia provides quality measures and guidance to ensure that such developments meet the highest standards of safety and efficacy.
Overall, the English version of the 2020 Pharmacopoeia represents a valuable resource for the pharmaceutical industry and individuals alike. The new release ensures that the latest standards are widely available and accessible across borders, making it easier to ensure the quality and safety of drugs sold and distributed in China from a global perspective. The Pharmacopoeia is an essential tool for ensuring the wellbeing of individuals and society as a whole and remains an important reference document in the ongoing efforts to improve global public health.
Here is the official Chinese Pharmacopoeia Commission website for access to the English version, however, it is nearly RMB8,000 per user for 5 years.
Reach out to Cisema if you have interest in any particular topics of the 2020 CP or discover our services for manufacturers of pharmaceuticals, packaging and ingredients.