On Jul. 2, 2020, the National Medical Product Administration (NMPA) and the National Health Commission (NHC) published the 2020 Edition of the Pharmacopoeia of the People's Republic of China (hereinafter referred to as Chinese Pharmacopoeia), which came into force on Dec. 30, 2020.
All finished pharmaceutical products with China's marketing authorization shall meet the technical requirements of dosage forms, test methods, guidelines, etc., in the Chinese Pharmacopoeia since Dec. 30, 2020.
Chinese Pharmacopoeia is a collection of standards for drug development, production, sales, utilization, supervision, and control in China. The 2020 edition is the 11th edition of Chinese Pharmacopoeia, covering 5,911 monographs of traditional Chinese medicines, chemical drugs, biologics, and pharmaceutical excipients.
Chinese Pharmacopoeia 2020 Edition
Traditional Chinese medicine (TCM) monographs
Chemical drug (including active chemical substance) monographs
Biologic product monographs
General requirements for preparations
Testing methods and other requirements
Pharmaceutical excipient monographs
Please refer to BaiPharm Database for the contents of the four volumes.
Chinese Pharmacopoeia 2020 English Version has been available since Mar. 14, 2023. Contact BaiPharm if you'd like to get access to the English version.
Drug Registration Application
Companies applying for drug registration after Dec. 30, 2020, shall provide drug registration materials according to the new Chinese Pharmacopoeia.
For registration applications that have been accepted by the Center for Drug Evaluation (CDE) by Dec. 30, 2020, but have not yet been completed for the technical review, the competent authorities will carry out the corresponding review and approval following the new Chinese Pharmacopoeia. If the applicants needs to provide additional technical information, they shall submit all the supplementary technical materials in one time.
A grace period of six months after acceptance is given for medicines that receive marketing approval before Dec. 30, 2020, to meet relevant requirements of the new Chinese Pharmacopoeia.
For medicines with marketing approval, if the previous registration standards contain more or different testing items or the quality parameters are stricter than those required by the new Chinese Pharmacopoeia, they shall implement the both corresponding requirements in the registration standards and the new Chinese Pharmacopoeia.
Medicines with registered standards containing fewer testing items or with less stringent quality parameters than that are specified in the new Chinese Pharmacopoeia shall meet the new Chinese Pharmacopoeia's requirements.
Equivalence Evaluation for Generic Drugs
For generic drugs that need to be evaluated for equivalence in quality and efficacy, but applying with registration standards different from the Chinese Pharmacopoeia 2020 Edition due to the particularity of dissolution, release rate and other items in quality control, the competent authorities shall include clarifications in the results of technical review.
The applicants can send proposals on revising the national pharmacopoeial standards to the Chinese Pharmacopoeia Commission within three months upon the approval of registration applications.
Post-marketing Changes to Drugs
According to the new Chinese Pharmacopoeia, for changes of formulations, manufacturing techniques, and suppliers of active pharmaceutical ingredients and excipients, the Marketing Authorization Holders (MAHs) and manufacturers shall conduct sufficient researches and tests according to relevant technical guidelines such as Provisions for Drug Registration and Good Manufacturing Practices (GMP) for Medical Products, and implement or report after the approval or filing of the corresponding changed applications.
The Chinese Pharmacopoeia 2020 Edition enriches general technical requirements and drug quality control guidelines. It sets standards for testing technology applications, testing items, and their limits. Its implementation will better guide medical researchers and MAHs to conduct drug research and control post-marketing quality.