On July 2, 2020, the National Medical Products Administration (NMPA) and the National Health Commission of the People’s Republic of China (NHC) announced the Chinese Pharmacopoeia 2020 Edition.
This is the 11th edition of Chinese Pharmacopoeia and will be officially implemented from December 30, 2020.
The Chinese Pharmacopoeia is published in 4 volumes:
Volume I:
Traditional Chinese medicines including medicinal materials, cut crude drugs, vegetable oils and extracts, formulation preparation and single flavour preparation;
Volume II:
Chemical drugs, antibiotics, biochemical drugs and radioactive drugs;
Volume III:
Biologics;
Volume IV:
General chapters for finished dosage forms, test methods, guidelines, reference substances, regents, test solutions, and pharmaceutical excipients.
1. Basic Information of Chinese Pharmacopoeia 2020 Edition
The Chinese Pharmacopoeia 2020 edition was compiled under a fixed framework. All goals under the framework have been achieved.
Achievement 1
An appropriate amount of finished pharmaceutical products have been newly listed in the 2020 edition.
This gives a total of 5,911 finished pharmaceutical products listed in the Chinese Pharmacopoeia.
Achievement 2
The 2020 edition deleted several standards of China finished pharmaceutical products to meet the new requirements.
Achievement 3
The 2020 edition comprehensively optimizes the standards of finished pharmaceutical products.
Technical requirements of quality control have been improved for:
- Traditional Chinese medicines,
- Chemical drugs,
- Biological products,
- APIs,
- Pharmaceutical excipients,
- Packaging materials,
- Reference substances.
General notices, general chapters of finished dosage forms, test methods and guidelines have been revised.
Achievement 4
The Chinese Pharmacopoeia 2020 edition has established and optimized the general naming conventions for standard drugs, pharmaceutical excipients and packaging materials.
Achievement 5
The Chinese Pharmacopoeia 2020 edition has improved common technical requirements for finished pharmaceutical products.
For example, the standards of traditional Chinese medicines are maintained at international standards, whereas the standards of chemical drugs and pharmaceutical excipients have nearly approached the international level.
Meanwhile, the standards of biological products have reached the international level and are closely related to novel scientific development.
Achievement 6
The international communication and cooperation between pharmacopoeia authorities has been further strengthened.
A variety of national pharmacopoeias have been further harmonized with each other and the international impact of Chinese Pharmacopoeia has been amplified.
2. Chinese Pharmacopoeia 2015 Edition VS 2020 Edition
You can find the differences between the number of products listed in the 2015 edition and 2020 edition of Chinese Pharmacopoeia below (Table 1).
| CATEGORY | NUMBER OF PRODUCTS LISTED IN 2015 EDITION | NUMBER OF PRODUCTS LISTED IN 2020 EDITION | |||
|---|---|---|---|---|---|
| Record | Addition | Revision | |||
| Traditional Chinese Medicines | 2594 | 2711 | 117 | 452 | |
| Chemical Drugs | 2595 | 2712 | 117 | 2387 | |
| Biological Products | 133 | 153 | 20 | 126 | |
| General Chapters | Finished Dosage Forms | 38 | 38 | 0 | 35 |
| Test Methods and Others | 246 | 281 | 35 | 51 | |
| Guidelines | 30 | 42 | 12 | 12 | |
| Excipients | 270 | 335 | 65 | 212 | |
| Total Number | 5906 | 6272 | 366 | 3275 |
