Comparison of interoperability among the standard systems of Chinese, the United States, European, and Japanese Pharmacopoeias and other standard systems

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Author: XU Xinyi ¹ LIU Zhen ² TAO Leran ³ SONG Haoyun ⁴ LI Dan ⁵ YU Wenli ⁶ WANG Guannan ⁷ LI Heng ⁸ WANG Yun ⁹  YANG Zhaopeng ¹

Affiliation: 1. Chinese Pharmacopoeia Commission, Beijing 100061, China 2. Jiangxi Institute for Drug Control, Nanchang 330029, China 3. School of Pharmaceutical Sciences, Capital Medical University, Beijing 100069, China 4. National Institutes for Food and Drug Control, Beijing 102629, China 5. MSD Research and Development (China) Co., Ltd, Beijing 100012, China 6. Organon (Shanghai) Pharmaceutical Technology Co., Ltd, Shanghai 200030, China 7. Bayer Healthcare Co., Ltd, Beijing 100176, China 8. Merck Serrano (Beijing) Pharmaceutical Research and Development Co., Ltd, Beijing 100016, China 9. China Association of Enterprises with Foreign Investment R&D-based Pharmaceutical Association Committee, Beijing 100125, China

Keywords: Pharmacopoeia System Standard Interoperability Comparison

DOI: 10.12173/j.issn.1008-049X.202401151

Reference: XU Xinyi, LIU Zhen, TAO Leran, SONG Haoyun, LI Dan, YU Wenli,WANG Guannan, LI Heng, WANG Yun, YANG Zhaopeng.Comparison of interoperability among the standard systems of Chinese, the United States, European, and Japanese Pharmacopoeias and other standard systems[J].Zhongguo Yaoshi Zazhi,2023,26(12):233-241.DOI: 10.12173/j.issn.1008-049X.202401151.[Article in Chinese]  Copied

Abstract
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Abstract

Objective To provide reference for the optimization and improvement of interoperability between the standard system of the Chinese Pharmacopoeia and other standards.

Methods The interoperability of various pharmacopoeia standard systems was compared by searching for citations from the Chinese Pharmacopoeia, the United States Pharmacopoeia-National Formulary, the European Pharmacopoeia, the Japanese Pharmacopoeia, and other standards, including references to domestic regulations and guidelines, standards of the International Organization for Standardization, guidelines from the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, documents of the World Health Organization, and standards from other countries and international organizations.

Results In recent years, pharmacopoeias in the world had continuously increased the citation of non pharmacopoeial standards. The types, quantities, and fields of the United States Pharmacopoeia-National Formulary referencing other standards far exceed those of other pharmacopoeias. The Chinese Pharmacopoeia cites the least number of other standards.

Conclusion It is suggested that the Chinese Pharmacopoeia should enhance the interoperability with other standard systems in the standards of various professional fields, enhance the openness, harmonization and advantages, and form a more complete standard system.

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