Interpretation and reflection on the Measures for the Administration of Standards for Medicinal Products / 中国药房

In July 2023， the National Medical Products Administration issued the Measures for the Administration of Standards for Medicinal Products （hereinafter referred to as the Measures）. This article interprets the main content of the Measures， and analyzes its shortcomings as unclear definition of the drug standard code and the goals of drug standard information construction. It is recommended that the national drug regulatory department promptly apply to the standardization authority for the confirmation of the drug standard code “YB” letter， and the drug standard code and numbering rules would be included in the next round of amendments to the Measures. It is necessary to clarify the construction goals of the information system for drug standards at the same time， and build a national drug standard data-sharing platform based on the basic framework of user interface layer， computing processing layer， and data storage layer. Digital drug standards will be free， and access and download services for the public will be provided.

Discussion on the legal attributes of provincial Chinese herbal pieces processing norms / 中国药房

OBJECTIVE To provide a reference for the definition of the legal attributes of the provincial Chinese herbal pieces processing norms and the improvement of legal expression for the drug standards in Drug Administration Law. METHODS Based on the legal evolution of local drug standards in China， the composition of national drug standards for Chinese herbal pieces and the composition of current provincial Chinese herbal pieces processing norms were analyzed； at the same time， based on the method of legal interpretation， the legal connotation of the provincial Chinese herbal medicine processing norms in Drug Administration Law was investigated. RESULTS & CONCLUSIONS In the practice of drug supervision， the provincial Chinese herbal pieces processing norms are essentially local drug standards. The newly revised Drug Administration Law defines the drug standards specifically， but does not stipulate the legal attribute of drug standards for the provincial Chinese herbal pieces processing norms， and there are certain legislative technical defects. It is suggested that when amending the Drug Administration Law， the legal attributes of the drug standards of the provincial Chinese herbal medicine processing norms should be clarified.

Analysis on the expression of drug standards and related issues in the newly revised Drug Administration Law / 中国药房

OBJECTIVE To sort out and analyze the expression and provisions of drug standards in the text of the newly revised Drug Administration Law ，and to explore the connotation and legal positioning of drug registration standards so as to provide reference for the rational application and interpretation of relevant provisions of drug standards in Drug Administration Law . METHODS Through the review of the evolution of drug standard management in China ，the legal provisions of drug standard in the Drug Administration Law were analyzed. Comparative study and literature research methods were used to analyze the legal expression and connotation of drug standards. RESULTS & CONCLUSIONS There were different expressions about “national drug standards ”“drug standards ”and“quality standards ”in the current provisions of the newly revised Drug Administration Law ； the legal position of the provincial-level standard for the preparation of Chinese herbal pieces was not clear ，and there may be insufficient legal regulation in the enforcement of drug administration. It is necessary to make an administrative interpretation for the content of relevant drug standards and provisions ，and further clarify the legal attributes of drug standards in the processing of provincial Chinese herbal pieces in order to promote the standardized management of Chinese herbal pieces.

A Discussion About the Organic Combination of National Drug Sampling and Testing for Quality Evaluation and National Drug Standards Improvement / 中国药学杂志

OBJECTIVEP: To explore the necessity and feasibility of organic combination of the national drug sampling and testing for quality evaluation and national drug standards improvement. METHODS: Through analysis of the similarities and differences of the two working modes and their complementarity, the problems that may arise in the connection of work were identified. The mechanism and counter measures to promote the organic combination of the two working modes were put forward. RESULT AND CONCLUSION: It was suggested that a communication mechanism should be established in time to strengthen the connection and interaction between the national drug sampling and testing for quality evaluation and national drug standard improvement, thus to avoid wasting resources and timely translate feasible suggestions into national drug standards.

Research on the Applicability of Drug Quality Standards in National Drug Sampling and Testing / 中国药学杂志

OBJECTIVE: To provide a reference to the use of quality standards in national drug sampling and testing, and establish the implementation plan. METHODS: By carding the approval process and usage flow of drug standards, analyzing approval form, authorized department, revise and numbering methods of the standard, composition and influencing factors of standard serviceability were studied. RESULTS AND CONCLUSION: The correctness and accuracy of the quality standards have a tremendous impact on national drug sampling and testing which is a significant measure of post-marketing surveillance. The article focuses on three aspects including the correctness, accuracy and orderliness, and then some solutions are proposed such as establishing the implementation plan and multi sector coordination, which can solve the problem of using standards in national drug sampling and testing.

Brief introduction of Chinese Pharmacopoeia 2015 edition volume IV / 中国药学杂志

The main significant change of the Chinese Pharmacopoeia (Ch. P) 2015 edition is the development of volume IV for the first time based on integrating the appendices of the Ch. P volume I (traditional Chinese drug), II (chemical drugs) and III (biologics), including the general requirements for preparations, testing methods, guidelines as well as the excipients standards. The Ch. P 2015 volume IV, as the general requirements, is the most important part of Ch. P. The Ch. P 2015 volume IV has made a great progress in improving testing methods, application of advanced analysis technology, strengthening process quality control, improving the control system for excipients as well as establishing the excipients monographs. It will play an important role in improving the overall standards of Ch. P, strengthening the drug quality control and assuring the drug quality.

Introduction to the national drug standards of radiopharmaceutical preparations and the main revision in the Chinese Pharmacopoeia 2015 edition / 中国药学杂志

The author summarized the national drug standards of radiopharmaceutical preparations and analyzed the existing problems, and gave a brief introduction about the revision in the Chinese Pharmacopoeia 2015 edition.

Overview on the Chinese Pharmacopoeia 2015 edition / 中国药学杂志

Chinese Pharmacopoeia (Ch. P) 2015 edition is the 10th revision of Ch. P since the People's Republic of China was established. The article is to describe the general situation about the development of Ch. P2015 edition, it will play very important role for the Ch. P 2015 on improving the standards system, strengthening the quality control for the drug, increasing the application of the advance detection technology, enlarging the monographs adoption, Improving the general requirements and control for the drug safety as well as the leading the international drug standards.

Reflection on Standardized Management of National Drug Standard in China / 中国药房

OBJECTIVE:To provide reference for standardized management of national drug standard in China.METHODS:Special inspections about the implementation of national drug standard were performed in pharmaceutical manufacturers of Deyang area.Based on the results of daily inspections,national drug standard was analyzed and discussed comprehensively.RESULTS:National drug standards were too many and diverse so that they influenced standardized management and implementation,which involved several aspects such as legality and seriousness of the management of drug standard,the conformity of relevant policy with drug standard,the standard of raw material and excipients,standardization of management approach for reference sample.CONCLUSION:Rigorous,complete and accurate national drug standards should be formulated,and relevant laws and regulations should be improved.Pharmaceutical enterprises can be urged to establish standardized drug standard file and to organize production and testing in accordance with national drug standard.