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The Pharmacopoeia of the People's Republic of China (Chinese Pharmacopoeia, or ChP is China’s official collection of standards for medicinal product research, production, sale, use, supervision, and control. It is produced by the Pharmacopoeia Commission of the People's Republic of China's Ministry of Health.
The World Health Organization (WHO) recognizes the ChP as China's official pharmacopoeia. All medicinal products must meet the ChP standards to receive marketing authorization in the country.
Every five (05) years, the Chinese Pharmacopoeia Commission updates the ChP. Up until now, eleven (11) versions have been published over the years. Here is a timeline of the ChP updates:
1953→1963→1977 →1985 →1990→1995 →2000→2005 →2010→2015→2020
The National Medical Product Administration (NMPA) and the National Health Commission (NHC) released the latest version of the ChP on July 02, 2020, and it has been effectively implemented since December 30, 2020.
The 2020 Issue is the eleventh one of the ChP. It contains 5,911 papers on traditional Chinese medicines, chemical drugs, biologics, and pharmaceutical excipients.
Table 1: Contents of the ChP 2020 Issue
Volume | Category | Number | |
Volume I | Traditional Chinese medicine monographs, including materials, cut crude drugs, vegetable oils and extracts, formulation preparations, and single-flavor preparations | 2,711 | |
Volume II | Chemical drug monographs, including active chemical substances | 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 excipient monographs | 335 | ||
Since the day the ChP 2020 was implemented, all finished pharmaceutical products with China’s marketing authorization have been required to meet its technical requirements for dosage forms, test methods, guidelines, and so on.
Is your product compliant with the standards and specifications laid out in the ChP? Our Regulatory experts can help you navigate the complex Regulatory landscape in China and ensure that your products meet the highest standards and specifications laid out in the ChP.
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