Announcement of the National Medical Products Administration on Matters Relating to the Implementation of the 2020 Edition of the Pharmacopoeia of the People’s Republic of China (No. 80 of 2020)

　　Release date: 2020-07-03

　　The 2020 Edition of the Pharmacopoeia of the People’s Republic of China (hereinafter referred to as the "Chinese Pharmacopoeia") has been promulgated by Announcement No. 78 of 2020 issued jointly by the National Medical Products Administration and the National Health Commission, and shall come into force as of December 30, 2020. The following announcement is hereby made regarding matters related to the implementation of this edition of the Chinese Pharmacopoeia:

　　1. According to the provisions of the Drug Administration Law, pharmaceutical products shall comply with national drug standards. The Chinese Pharmacopoeia is an important component of the national drug standards and serves as the legally mandated technical standard that all relevant entities—including those involved in drug research and development, manufacturing (including importation), distribution, use, and regulatory oversight—must follow.

　　II. The Chinese Pharmacopoeia consists primarily of Preface, Monographs on Individual Substances, and General Technical Requirements. From the date of implementation, all pharmaceutical products marketed shall comply with the relevant technical requirements set forth in this edition of the Chinese Pharmacopoeia.

　　3. From the date of implementation, any monographs originally included in previous editions of the Pharmacopoeia or in standards issued by the National Medical Products Administration (NMPA) and local authorities that are now included in this edition of the Chinese Pharmacopoeia shall have their corresponding previous editions of the Pharmacopoeia and NMPA/local authority standards simultaneously abolished. For those monographs not included in this edition of the Chinese Pharmacopoeia, the corresponding previous editions of the Pharmacopoeia and NMPA/local authority standards shall continue to be applied, provided that they comply with the relevant general technical requirements set forth in this edition of the Chinese Pharmacopoeia. Monographs that have been withdrawn or cancelled following post-marketing evaluation shall have their corresponding previous editions of the Pharmacopoeia and NMPA/local authority standards simultaneously abolished.

　　For preparation specifications and manufacturing methods of traditional Chinese medicines not included in the main text of this edition of the Chinese Pharmacopoeia, their quality standards shall be implemented in accordance with the relevant requirements for the same items in this edition of the Chinese Pharmacopoeia. The specification and manufacturing method sections shall be governed by the originally approved documentation.

　　4. If the inspection items listed in the drug registration standards exceed or differ from those specified in the Pharmacopoeia, or if the quality indicators are stricter than the requirements of the Pharmacopoeia, the corresponding items and indicators of the registration standards shall be implemented concurrently with compliance to the Pharmacopoeia requirements.

　　If the drug registration standards include fewer test items than those specified in the Pharmacopoeia or have quality indicators lower than the requirements of the Pharmacopoeia, the Pharmacopoeia specifications shall prevail.

　　5. Given the special nature of parameters such as dissolution and release in quality control, if the registration standards for generic drugs approved in accordance with the requirements for evaluating the consistency of quality and efficacy of generic drugs differ from those specified in the Chinese Pharmacopoeia, the National Medical Products Administration shall state this in its approval conclusion. Within three months after the approval of the corresponding registration application, the applicant shall submit a proposal to the National Pharmacopoeia Committee for revising the national drug standards. Until the Chinese Pharmacopoeia has completed its revision, the approved drug registration standards may continue to be applied.

　　6. To comply with the requirements of this edition of the Chinese Pharmacopoeia, if any changes are involved in aspects such as drug formulations, manufacturing processes, and sources of raw and excipient materials, the marketing authorization holder and the manufacturer shall conduct thorough studies and validations in accordance with the "Drug Registration Management Measures," relevant technical guidance principles for change studies, and Good Manufacturing Practice for Pharmaceuticals, and shall implement or report such changes only after obtaining approval or filing according to the corresponding change category.

　　7. For drugs whose generic names have been revised in this edition of the Chinese Pharmacopoeia, the names specified in this edition of the Chinese Pharmacopoeia shall be used; the original names may continue to be used as former names on a transitional basis.

　　8. From the date of implementation of this edition of the Chinese Pharmacopoeia, drug registration applications submitted shall have their supporting documentation comply with the relevant requirements of this edition of the Chinese Pharmacopoeia.

　　For registration applications that have been accepted but not yet completed technical review prior to the implementation date of this edition of the Chinese Pharmacopoeia, from the date of implementation of this edition of the Chinese Pharmacopoeia, the drug regulatory authorities shall conduct the corresponding review and approval in accordance with the relevant requirements of this edition of the Chinese Pharmacopoeia. Applicants who are required to supplement technical data shall submit all such supplementary materials in one single submission.

　　Medicines approved for marketing in accordance with the relevant requirements of the previous edition of the Chinese Pharmacopoeia after its publication date but before its implementation date shall comply with the relevant requirements of this edition of the Chinese Pharmacopoeia within six months following approval.

　　9. Holders of drug marketing authorization, pharmaceutical manufacturers, and applicants for drug registration should actively prepare for the implementation of this edition of the Chinese Pharmacopoeia. They should promptly report any issues encountered during the implementation of the Chinese Pharmacopoeia to the National Pharmacopoeia Committee. At the same time, they should continuously conduct research to refine and improve drug quality standards, thereby steadily enhancing the level of drug quality control.

　　10. Each provincial drug administration department should cooperate in promoting and implementing the 2020 Edition of the Chinese Pharmacopoeia, strengthen supervision and guidance during the implementation of this edition, and promptly collect and provide feedback on any related issues and suggestions.

　　11. The National Pharmacopoeia Committee is responsible for the unified organization and coordination of the promotion, training, and technical guidance related to the 2020 Edition of the Chinese Pharmacopoeia. It has established a dedicated “Implementation Column for the 2020 Edition of the Chinese Pharmacopoeia” on its official website and will promptly address any issues raised during implementation.

　　Hereby announced.

　　National Medical Products Administration

　　July 3, 2020