The latest notice of the new version of the Pharmacopoeia is here

Pharmaceutical Network July 7th, the new version of the Pharmacopeia, the latest notice cameOn July 3, the State Drug Administration issued the "Announcement on the Implementation of the 2020 Edition of the Pharmacopoeia of the People's Republic of China" (hereinafter referred to as the "Announcement"), which will be announced on matters related to the Chinese Pharmacopoeia, which will be implemented from December 30, 2020This is the implementation of the 2020 edition of the Pharmacopoeia after the official announcement of the 2020 edition of the People's Republic of China Pharmacopoeia (No78 of 2020) officially issued by the State Drug Administration and the State Health and Care Commission on July 2It is understood that the 2020 edition of the Chinese Pharmacopoeia added 319 varieties, revised 3177 species, no longer loaded 10 species, varieties adjusted and combined 4 species, a total of 5911 varietiesOne Chinese medicine contains 2711 kinds, of which 117 are added and 452 are revisedIn the safety control of Chinese medicine, the new version of the pharmacopeia requires effective control of the effects of exogenous pollutants, and effective control of endogenous toxic ingredients on the safety of Chinese medicineIn the control of the effectiveness of Chinese medicine, it is necessary to strengthen the exclusiveness and integrity of the standards, focusing on the study of biological evaluation and measurement methods based on the clinical efficacy of Chinese medicineTwo chemical strains contained 2712 kinds, of which 117 were added and 2387 were revisedIn the area ofdrugsafety control, it is required to further improve the analysis methods of impurities and related substances, popularize the application of advanced testing techniques, focus on strengthening the control of toxic and harmful impurities (especially genetically toxic impurities), and strengthen the study and formulation of drug safety-related control projects and limit standardsIn the field of drug effectiveness control, it is required that the results of the evaluation of drug quality and efficacy consistency are reflected in the improvement of the quality standards of the relevant preparations, and the methods of detection of the dissolved and release degree of conventional solid preparations are further improved, and the international requirements are further learned in the overall quality controlThree biological products contain 153 species, of which 20 new, revised 126 species;In addition, we will further improve the quality control requirements of the whole process of biological products, complement and improve biological testing technology, methods and related technical guidelines, improve the variety collection category, and speed up the collection of mature vaccines and therapeutic biological drugs approved for market in Recent yearsThe four collection of general technology requirements 361, of which 38 (revised 35), testing methods and other general rules 281 (new 35, revised 51), guiding principle
s 42 (12 new, revised 12
); 　　According to the Law on drug administration, drugs should comply with national drug standards, the bulletin said The Chinese Pharmacopoeia is an important part of the national drug standards, and is the legal technical standard that all relevant units such as drug development, production (import), operation, use and supervision and management should follow From the date of implementation, all production and listed drugs shall comply with the relevant technical requirements of the Chinese Pharmacopeia 　　In addition, the Bulletin also requires that, from the date of implementation, where the original collection contained in the past edition of the Pharmacopoeia, bureau (ministry) issued standards of varieties, this edition of the "Chinese Pharmacopoeia" contained, the corresponding calendar version of the Pharmacopoeia, Bureau (Ministry) issued standards at the same time abolished; If not collected, the corresponding calendar version of the Pharmacopeia, Bureau (department) issued standards, but should comply with the relevant general technical requirements of this edition of the Chinese Pharmacopoeia, after the listing of the evaluation of the cancellation or cancellation of the varieties, the corresponding calendar version of the Pharmacopoeia, bureau (department) issued standards to be abolished The quality standards of the preparation specifications and the method of chinese medicine, which are not included in the body of the Chinese Pharmacopoeia, shall be implemented in accordance with the relevant requirements of the Chinese Pharmacopoeia, and the specification sandors and the law-making items shall be implemented according to the original approval supporting documents respectively 　　In addition, the "Announcement" also approved the registration standards of generic drugs approved by the consistency evaluation requirements are different from the Chinese Pharmacopeia drugs: , that is, due to the particularity of the solubility, release degree and other items in quality control, in accordance with the generic drug quality and efficacy consistency evaluation requirements approved in the registration standards of generic drugs are different from the "Chinese Pharmacopoeia", the State Drug Administration in the approval conclusions to explain, the applicant in the corresponding registration application for approval of the national drug standards 　　The Chinese Pharmacopeia is the core of China's drug standard system and the legal basis for drug research, production, operation, use and supervision With the implementation of the new version of the pharmacopeia, the pharmaceutical industry will usher in a new round of changes and challenges 　　Attached to the Full Notice the State Drug Administration's announcement on the implementation of the 2020 edition of the Pharmacopoeia of the People's Republic of China (No 80 of 2020) the 2020 edition of the "Chinese Pharmacopoeia" (hereinafter referred to as the "Chinese Pharmacopoeia") has been issued by the State Drug Administration, the National Health Health Commission No 78 of 2020, and will be implemented from December 30, 2020 Here is the announcement on the implementation of this edition of the Chinese Pharmacopoeia as follows: , according to the provisions of the Drug Administration Law, drugs should comply with the national drug standards The Chinese Pharmacopoeia is an important part of the national drug standards, and is the legal technical standard that all relevant units such as drug development, production (import), operation, use and supervision and management should follow 　　Second, the Chinese Pharmacopoeia is mainly composed of exceptional examples, the body of varieties and general technical requirements From the date of implementation, all production and listed drugs shall comply with the relevant technical requirements of this edition of the Chinese Pharmacopoeia 　　3 From the date of implementation, where the original collection contains in the previous edition of the Pharmacopoeia, bureau (department) issued standards of the varieties, this edition of the "Chinese Pharmacopoeia" received, the corresponding calendar version of the Pharmacopoeia, bureau (ministry) issued standards shall be abolished at the same time; If it is loaded, the corresponding calendar version of the Pharmacopeia, Bureau (Department) issued standards, but should comply with the relevant general technical requirements of this edition of the Chinese Pharmacopoeia, after the listing of the evaluation of the varieties revoked or cancelled, the corresponding calendar version of the Pharmacopoeia, bureau (ministerial) issued standards to abolish 　　The quality standards of the preparation specifications and the method of chinese medicine, which are not included in the body of the Chinese Pharmacopoeia, shall be implemented in accordance with the relevant requirements of the Chinese Pharmacopoeia, and the specification sandors and the law-making items shall be implemented according to the original approval supporting documents respectively 　　4 If the drug registration the standard contains more inspection items than or is different from the requirements of the Pharmacopeia, or the quality indicators are strictly in accordance with the requirements of the Pharmacopeia, the corresponding items and indicators of the registration standards shall be implemented on the basis of the implementation of the requirements of the Pharmacopeia 　　If the drug registration standard contains less than the pharmacopeia requirements or the quality index is less than the pharmacopeia requirement, the provisions of the pharmacopeia shall be implemented 　　5 Because of the particularity of the solubility degree, release degree and other items in quality control, the registration standards for generic drugs approved in accordance with the requirements of the quality and efficacy consistency evaluation of generic drugs are different from the Chinese Pharmacopeia, the State Drug Administration explains in the approval conclusions, and the applicant submits to the State Pharmacopeia Commission a proposal to revise the national drug standards within three months after the approval of the corresponding registration application Before the revision of the Chinese Pharmacopoeia is completed, it may be implemented in accordance with the approved drug registration standards 　　6 In order to comply with the requirements of this edition of the Chinese Pharmacopoeia, such as changes involving drug prescriptions, production processes and sources of raw materials, the drug market licensing holders, production enterprises shall conduct full research and verification in accordance with the Measures for the Administration of Drug Registration and Research and the relevant requirements for the technical guidelines for change research and the quality management norms for pharmaceutical production, and shall be approved, filed or reported according to the corresponding change categories 　　7 The drugs whose generic name has been revised in this edition of the Chinese Pharmacopoeia shall be used using the name specified in this edition of the Chinese Pharmacopoeia, whose original name may be used as a transitional name 　　8 From the date of the implementation of this edition of the Chinese Pharmacopoeia, the corresponding declaration information shall comply with the relevant requirements of this edition of the Chinese Pharmacopoeia 　　The registration application for the technical review that has been accepted before the date of the implementation of this edition of the Chinese Pharmacopoeia shall be submitted by the drug regulatory department in accordance with the relevant requirements of this edition of the Chinese Pharmacopoeia, and the applicant who needs to supplement the technical information shall be submitted at one time 　　The drugs approved for listing after the date of publication of this edition of the Chinese Pharmacopeia and before the date of implementation shall meet the relevant requirements of this edition of the Chinese Pharmacopoeia within 6 months after approval 　　9 Drug listing license holders, manufacturers of enterprises and drug registration applicants shall actively prepare for the implementation of this edition of the Chinese Pharmacopoeia, report to the State Pharmacopeia Commission in a timely manner on the problems found in the course of the implementation of the Chinese Pharmacopeia, and continue to study and improve the quality standards of pharmaceuticals and continuously improve the quality control level of pharmaceuticals 　　The provincial drug supervision and administration departments shall cooperate with the publicity and implementation of the 2020 edition of the Chinese Pharmacopoeia, strengthen the supervision and guidance in the implementation of this edition of the Pharmacopoeia, and collect and feedback relevant issues and opinions in a timely manner 　　The State Pharmacopeia Commission is responsible for unifying the organization and coordination of the 2020 edition of the China Pharmacopoeia's public training and technical guidance work, and has opened an executive column on the 2020 edition of the Chinese Pharmacopoeia on its official website to answer the questions reflected in the implementation