New edition of Chinese Pharmacopoeia

- Jul 13, 2020-

The National Pharmacopoeia Commission published an article titled "Basic Overview and Main Features of the Chinese Pharmacopoeia 2020 Edition", which mentioned that the official implementation time of the 2020 Chinese Pharmacopoeia was December 1, 2020.

In the article "Basic Overview and Main Features of the 2020 Edition of the Chinese Pharmacopoeia", Volume 21, Issue 3 of the Chinese Journal of Pharmaceutical Standards, the changes of the new Pharmacopoeia are summarized and analyzed, which discloses that the new Pharmacopoeia adds 319 Species, revised 3177 species, no longer included 10 species, 4 species merged and adjusted, a total of 5911 species were included. A total of 2711 kinds of traditional Chinese medicines are included, of which 117 kinds are newly added and 452 kinds are revised. The second part contains 2712 kinds of chemical drugs, of which 117 kinds are newly added and 2387 kinds are revised. The three parts of biological products contain 153 kinds, of which 20 kinds are newly added and 126 kinds are revised; 2 general rules of newly added biological products and 4 in general. The four parts contain 361 general technical requirements, including 38 general rules for preparations (revised 35), 281 detection methods and other general rules (newly added 35, revised 51), and 42 guidelines (newly added 12, revised 12) ); 335 kinds of medicinal excipients are collected, of which 65 kinds are newly added and 212 kinds are revised (see Table 1).

Comparison of Chinese Pharmacopoeia 2015 Edition and 2020 Edition Collection


Category


Number of 2015 Pharmacopoeia varieties


Number of pharmacopoeia varieties in 2020


Collect


New


Revision


traditional Chinese medicine


2598


2711


117


452


Chemical medicine


2603


2712


117


2387


medical supplements


270


335


65


212


Biological Products


137


153


20


126


Variety total


4567


5608


1082


1134


General


Preparation General


38


38


/


35


Inspection methods and others


246


281


35


51


Guiding Principles


30

The article also pointed out the main features of the new version of the pharmacopoeia:


1. Steadily promote the collection of pharmacopoeia varieties


2. Pharmacopoeia standard system is further improved


3. The application of mature analysis and detection technology is further expanded


4. Drug safety control requirements continue to strengthen


5. Continuous improvement of drug effectiveness control


6. The whole process quality control system is gradually constructed


7. The standard level of accessories is further improved


8. International standard coordination is further strengthened


9. Pharmacopoeia's guiding role is further strengthened