Chinese Pharmacopoeia 2020

On March 14, 2023, the Chinese Pharmacopoeia Commission (CPC) formally issued the English translation of the Chinese Pharmacopoeia 2020 edition. On July 2, 2020, the Chinese version was made available, and it went into effect on December 30, 2020. The publication is a vital resource for pharmaceutical manufacturers and users worldwide since it offers a thorough summary of China's quality standards and criteria for medications and pharmaceutical products.

The 2020 Edition of the Pharmacopoeia of the People's Republic of China (henceforth referred to as the Chinese Pharmacopoeia) was issued by the National Medical Product Administration (NMPA) and the National Health Commission (NHC). It becomes effective on December 30, 2020.

 

Since December 30, 2020, all completed pharmaceutical goods having marketing authorisation from China must adhere to the technical specifications of the Chinese Pharmacopoeia, including dosage forms, test procedures, guidelines, etc. 

 

 

A set of guidelines for medication discovery, manufacturing, distribution, use, oversight, and control in China is known as the Chinese Pharmacopoeia. The 11th edition of the Chinese Pharmacopoeia, published in 2020, has 5,911 monographs on chemical pharmaceuticals, biologics, pharmaceutical excipients, and traditional Chinese remedies.

Table 1: Chinese Pharmacopoeia 2020 Edition Volumes

Volume	Content		Number
Volume I	Monographs of traditional Chinese medicines (TCMs)		2,711
Volume II	Monographs of chemical drugs		2,712
Volume III	General monographs of biological products		8
	General requirements for biological products		8
	Monographs of biological products		153
Volume IV	General chapters	General requirements for preparations	38
		General testing methods and other general chapters	281
		Guidelines	42
	Monographs of pharmaceutical excipients		335

Notice of Update (2025):
The Chinese Pharmacopoeia has undergone a revision. Please read our recently published article for the most recent standards and updates:  Chinese Pharmacopoeia 2025: Important Changes and Essential Information

Highlights
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:

 

 

1. Volume I of the CP includes 2711 monographs for traditional Chinese medicine (TCM), with 117 additions and 452 revisions.
2. Volume II includes 2712 monographs for chemical drugs, with 117 additions and 2387 revisions.
3. Volume III includes 153 monographs for biological products, with 20 additions and 126 revisions.
4. 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.

The emphasis on contemporary technologies and innovative medication development methodologies in the most recent edition of the Pharmacopoeia is one of its key characteristics. This makes it a more thorough and complete reference to the most recent developments in the field, including new guidelines on biologics, traditional Chinese medicines, and complementary therapies.

The 2020 Pharmacopoeia places a special emphasis on innovation and development in order to stay up with the pharmaceutical industry's rapid changes. The Pharmacopoeia offers quality standards and guidelines to guarantee that new discoveries satisfy the highest standards of safety and efficacy, whether they involve new production methods, the introduction of new medication categories, or developing drug delivery modalities.

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 well being of individuals and society as a whole and remains an important reference document in the ongoing efforts to improve global public health.

 

 

 

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