On July 2, 2020, the National Medical Products Administration (NMPA) and the National Health Commission of the People’s Republic of China (NHC) released an announcement on promulgating the 2020 edition of the Pharmacopoeia of the People’s Republic of China (hereinafter referred to as Chinese Pharmacopoeia). This is the 11th edition of Chinese Pharmacopoeia and will be implemented officially 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 flavor 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 2020 Edition
The Chinese Pharmacopoeia 2020 edition was compiled under the fixed framework of which all goals have been achieved.
Achievement 1: an appropriate amount of finished pharmaceutical products have been newly listed in the 2020 edition, which gives a total of 5,911 finished pharmaceutical products listed in the Chinese Pharmacopoeia.
Achievement 2: the 2020 edition has made several deletions in the standards of China finished pharmaceutical products to meet the new requirements.
Achievement 3: the 2020 edition has comprehensively optimized 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 and reference substances. General notices, general chapters of finished dosage forms, test methods and guidelines have been newly revised.
Achievement 4: the 2020 edition has established and optimized the general naming conventions for standard drugs, pharmaceutical excipients and packaging materials.
Achievement 5: the 2020 edition has further improved the common technical requirements for finished pharmaceutical products, i.e. the standards of traditional Chinese medicines are maintained to be the 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 have 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. 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 in the table below (Table 1).
3. Main Characteristics of 2020 Edition
1) The Chinese Pharmacopoeia is mainly composed of general notices, monographs and general technical requirements. All finished pharmaceutical products with China marketing authorization shall meet the technical requirements in Chinese Pharmacopoeia since the day of implementation.
2) Further improvement of standards in Chinese Pharmacopoeia
3) Further applications of advanced technology in product analysis and testing
4) Consistent improvement of safety control requirements for finished pharmaceutical products
5) Consistent improvement of drug efficacy control
6) Stepwise establishment of a control system for the whole-process quality of pharmaceutical manufacturing
7) Further improvement of pharmaceutical excipient standards
8) Further harmonization of international standards
9) Further promotion of Chinese Pharmacopoeia as the guidance for the pharmaceutical industry
4. Highlights of Announcement 2020
1） The Chinese Pharmacopoeia is mainly composed of general notices, monographs and general technical requirements. All finished pharmaceutical products with China marketing authorization shall meet the technical requirements in Chinese Pharmacopoeia since the day of implementation.
2） In the drug registration standards, test items which are not included or not in line with those in the Chinese Pharmacopoeia, or quality parameters which have higher criteria than those in the Chinese Pharmacopoeia, shall be conducted or used not only in accordance with the drug registration but also the Chinese Pharmacopoeia standards. In the opposite situation, the drug registration standards which include less test items than the pharmacopoeial standards, or lower quality parameter criteria than those in the pharmacopoeial standards, should be implemented according to the Chinese Pharmacopoeia.
3） Due to the particular criteria of dissolution and release rate in drug quality control, for those generics which have criteria different from the pharmacopoeial criteria but were approved for the consistency evaluation of quality and efficacy, the national supervision and administration authorities shall include clarifications in the results of technical review, and the applicants can submit proposals on how to revise the pharmacopoeial standards to the Chinese pharmacopoeia authority within three months upon approval of registration applications.
4） In order to meet the requirements of Chinese Pharmacopoeia, for changes of formulations, manufacturing process and suppliers of APIs and excipients, the Marketing authorization Holders (MAHs) and manufacturers shall conduct comprehensive studies and validations according to the Provisions for Drug Administration, technical guidelines for change-related studies and GMP requirements, and implement or report after the change applications being approved or filed.
5） Finished pharmaceutical products whose names have been revised according to the general naming conventions can have their original names as former names for the transition period.
6） Since the day of implementing the 2020 edition, application materials for registrations of finished pharmaceutical products shall meet relevant requirements in the Chinese Pharmacopoeia.
7） For registration applications which have been accepted and not reviewed for approval, the national supervision and administration authorities should conduct technical reviews according to relevant requirements of the Chinese Pharmacopoeia upon implementation of the 2020 edition, and the applicants shall supplement relevant technical materials within single submissions.
8） Finished pharmaceutical products which were approved for marketing authorizations according to relevant requirements of the previous Chinese Pharmacopoeia in the transition period of promulgating and implementing the 2020 edition, should meet the requirements of the 2020 edition within 6 months upon approval.