New Standards, Methods, and Technologies: 2025 Chinese Pharmacopoeia Quality Control and Testing Standards Interpretation Training Successfully Concluded in Xi'an
March 11–12, 2025, co-organized by the Xi’an Pharmaceutical Association, Suzhou Danhuang Technology Co., Ltd., and Beijing Chengfeng Jihai Technology Co., Ltd.【New Standards, New Methods, and New Technologies: Training on the Interpretation of Quality Control and Testing Standards in the 2025 Edition of the Pharmacopoeia】Successfully held at the Xi’an Hotel in Xi’an. The training event brought together authoritative experts from China and abroad in the fields of pharmaceutical R&D analysis and production testing, who shared their extensive experience and case studies accumulated over many years across multiple domains, including biologics, biochemistry, physicochemical analysis, and traditional Chinese medicine.
Conference Venue
Xiao Jun, Director of the Xi'an Pharmaceutical Association and Chairman of Shaanxi Hantang Pharmaceutical Co., Ltd.Serving as the moderator for this session of leadership addresses,Dou Jianwei, Supervisor of the Xi'an Pharmaceutical Association and Associate Professor at the School of Pharmacy, Xi'an Jiaotong University、Shan Min, Secretary-General of the Xi'an Pharmaceutical Association、Wu Tingting, Deputy Secretary-General of the Xi'an Pharmaceutical AssociationThree leaders delivered the opening remarks for this training event. Ms. Shan Min andChen Ping, Secretary-General of the Shaanxi Provincial Association for Research and Development of Traditional Chinese Medicine Science and Technology, and Researcher at the Shaanxi Provincial Academy of Traditional Chinese MedicineServe as the moderator for this training session.
Xiao Jun, Director of the Xi'an Pharmaceutical Association and Chairman of Shaanxi Hantang Pharmaceutical Co., Ltd.
Dou Jianwei, Supervisor of the Xi'an Pharmaceutical Association and Associate Professor at the School of Pharmacy, Xi'an Jiaotong University
Shan Min, Secretary-General of the Xi'an Pharmaceutical Association
Wu Tingting, Deputy Secretary-General of the Xi'an Pharmaceutical Association
Hu Haobin, Deputy Director of the Traditional Chinese Medicine Laboratory, Jiangsu Institute for Food and Drug ControlHe delivered a keynote speech titled “A Brief Analysis of Traditional Chinese Medicine Standards and Changes in the 2025 Edition of the Pharmacopoeia.” He elaborated on six aspects: the TCM standard system, general notices of the Pharmacopoeia and changes related to TCM in the 2025 edition, general chapters of the Pharmacopoeia and changes related to TCM in the 2025 edition, changes in technical guidelines for the 2025 edition of the Pharmacopoeia, and key considerations for testing under the new Pharmacopoeia. These aspects covered changes in quality testing standards, general testing rules, identification methods, and impurity testing methods for TCM preparations, crude TCM materials, and decoction pieces in the 2025 edition of the Pharmacopoeia.
Hu Haobin, Deputy Director of the Traditional Chinese Medicine Department, Jiangsu Institute for Food and Drug Control
Li Hui, Manager of the Quality Control Department, Shaanxi Buchang Pharmaceutical Co., Ltd.Delivered a presentation titled “Laboratory Data Management and Risk Control.” She provided a comprehensive and in-depth analysis of the key steps in laboratory data management, as well as risk control strategies and response measures in the laboratory setting.
Li Hui, Manager of the Quality Control Department at Shaanxi Buchang Pharmaceutical Co., Ltd.
Peng Yifang, Senior Application Engineer at the Analysis Center of the Analytical & Measuring Instruments Division, Shimadzu Enterprise Management (China) Co., Ltd.Delivered a keynote presentation on the “Comprehensive Solution for the Public Draft on Traditional Chinese Medicine Safety in the 2025 Edition of the Chinese Pharmacopoeia.” From four perspectives—testing for prohibited and restricted pesticide residues in traditional Chinese medicinal materials, testing for plant growth regulators in traditional Chinese medicinal materials, testing for colorants in traditional Chinese medicinal materials, and detection of aristolochic acid I in Chinese patent medicines—Peng Yifang introduced Shimadzu’s product solutions.
Peng Yifang, Senior Application Engineer at the Analysis Center of the Analytical & Measuring Instruments Division, Shimadzu Enterprise Management (China) Co., Ltd.
Former Director of the Chemical Drug Division, National Institutes for Food and Drug ControlDelivered a presentation titled “Harmonization of ICH Q4B.” He addressed four key aspects: background, work conducted, implementation approach, and major additions and revisions.ICH Q4B Conducted a Comprehensive Analysis.
Former Director of the Chemical Drug Division, National Institutes for Food and Drug Control (NIFDC)
Gao Hua, Former Director of the Pharmacology Division at the National Institutes for Food and Drug ControlDelivered a knowledge-sharing session on “Challenges Facing the Bacterial Endotoxin Test for Injections and Research into Alternative Methods.” The presentation provided an insightful exposition on four key areas: an overview of bacterial endotoxin testing technologies, challenges associated with the Bacterial Endotoxin Test (BET), regulatory requirements for BET in the 2025 edition of the Chinese Pharmacopoeia, and recent advances in BET methodology research.
Gao Hua, Former Director of the Pharmacology Department at the National Institutes for Food and Drug Control (NIFDC)
Zhao Haishan, General Manager of Tianjin Tianda Tianfa Technology Co., Ltd.
Mo Shuijing, Chairman of Zhanjiang Bokang Marine Biotechnology Co., Ltd.
Roundtable Discussion: A Comparison of the Current State of R&D and Quality Control in China with International Standards
The roundtable discussion session of this training is themed around“Comparison of the Current Status of R&D and Quality Control in China with International Standards”as the theme,Egg Yolk Technology (VCBeat) Partner Wu XuetaoModerated by the host, Gao Hua, former Director of the Pharmacology Department at the National Institutes for Food and Drug Control; Li Hui, Manager of the Quality Control Department at Shaanxi Buchang Pharmaceutical Co., Ltd.; Zhao Haishan, General Manager of Tianjin Tianda Tianfa Technology Co., Ltd.; and Mo Shuijing, Chairman of Zhanjiang Bokang Marine Biology Co., Ltd., engaged in a vibrant discussion on multiple topics. These included key considerations for enhancing quality standards of traditional Chinese medicine (TCM), whether automated testing offers advantages over manual testing for products exported to the U.S. market, and performance differences between natural limulus amebocyte lysate (LAL) and recombinant factor C (rFC) reagents.
Wei Shifeng, Ph.D. & Chairman of Beijing Luonuoqiangshi Pharmaceutical Technology R&D Center Co., Ltd.Delivered a presentation titled《Presentation Report on “New Standards and Heights in International Drug R&D: Interpretation of Quality Control in Overseas Drug Development Stages.” He provided a step-by-step analysis and explanation from the perspectives of design space cases, innovative formulation cases, key points in pilot-scale manufacturing process development, basis for formulation quality, and pilot-scale scale-up process studies. He emphasized that product development quality must align with clearly defined clinical needs and manufacturing technologies.
Dr. Wei Shifeng, Ph.D. & Chairman of Beijing Luonuoqiangshi Pharmaceutical Technology R&D Center Co., Ltd.
Li Zhanjun, Former Chief Pharmacist of the Biochemistry Division at the National Institutes for Food and Drug ControlShe delivered a presentation titled “Biochemical Drugs and Recombinant Hormones Related to Bioassays and Their Revisions and Additions in the 2025 Edition of the Chinese Pharmacopoeia.” Focusing on four areas—bioassays, recombinant human growth hormone, recombinant human insulin, and recombinant human follicle-stimulating hormone—she provided a detailed explanation of the revised and added content concerning bioassays in the four general chapters.
Li Zhanjun, Former Chief Pharmacist of the Biochemistry Laboratory at the National Institutes for Food and Drug Control
Zhou Shiying, Product Manager of the High-Performance Liquid Chromatography Marketing Department, Wukong Scientific Instruments (Shanghai) Co., Ltd., Hanon GroupShe delivered a presentation titled “K2025: Efficiently Meeting the New HPLC Standards of the Pharmacopoeia,” in which she provided a brief analysis of the updates to the high-performance liquid chromatography (HPLC) methods in the 2025 edition of the Chinese Pharmacopoeia, as well as the changes to Chapter 0512 (HPLC) of the 2025 Chinese Pharmacopoeia, and gave a detailed introduction to Wukong K2025.Reliability, Precision, User-Friendliness, and Compliance of High-Performance Liquid Chromatography (HPLC) Systems
Zhou Shiying, Product Manager of the High-Performance Liquid Chromatography (HPLC) Marketing Department at Haoneng Group Wukong Scientific Instruments (Shanghai) Co., Ltd.
Zhang Feifei, Technical Support Engineer at Shanghai Shanpu Biotechnology Co., Ltd.Delivered a presentation on the “Solution for Bacterial Endotoxin Testing (Microplate Method).” He analyzed the current status of endotoxin analysis and discussed the developments by Shanghai Shanpu Biotechnology.Endotoxin TestingA detailed introduction to the instrumental analysis protocol.
Zhang Feifei, Technical Support Engineer at Shanghai Spectrum Biotechnology Co., Ltd.
Hou Hongjun, Director of the Drug Production Supervision Division, Shaanxi Provincial Medical Products AdministrationHe delivered a keynote speech titled “Interpretation of China’s Policies on Innovative Drugs.” He provided an in-depth analysis of the current state of China’s pharmaceutical industry, core policies related to innovative drugs in China, and future development trends. He believes that driven by factors such as the continuous release of policy dividends, innovation fueled by technological breakthroughs, market expansion propelled by commercial health insurance, and the gradual maturation of the R&D ecosystem, the market size of innovative drugs in China will reach new heights, demonstrating strong growth potential.
Hou Hongjun, Director of the Drug Production Supervision Division, Shaanxi Provincial Medical Products Administration
Li Xia, Director of the Business Department, Shaanxi Institute for Food and Drug ControlShe delivered a presentation titled “Introduction to Domestic and International Technical Guidelines for Analytical Method Development.” She began byQbD ConceptA comprehensive and in-depth interpretation of domestic and international technical guidelines for analytical procedure development was conducted from four perspectives: applications in analytical procedures, an introduction to USP General Chapter <1220>, an overview of ICH Q14 on analytical procedure development, and acceptance criteria for analytical procedure development.
Li Xia, Director of the Business Department, Shaanxi Institute for Food and Drug Control
Liu Haijing, Former Secretary of the Party Committee and President of Shaanxi Provincial Institute for Drug ControlShe delivered a presentation titled “Key Points in Quality Control of Imported and Exported Pharmaceuticals.” She provided an in-depth analysis of regulatory requirements for imported and exported pharmaceuticals, pharmaceutical products subject to import and export controls, GMP oversight for exported pharmaceuticals, traditional Chinese medicine preparations, examples of differences in quality standards for imported and exported pharmaceuticals, and comparisons of foreign pharmacopoeias.
Liu Haijing, Former Party Secretary and President of the Shaanxi Provincial Institute for Drug Control
Special Acknowledgements
The successful conclusion of this event would not have been possible without the dedicated efforts of numerous behind-the-scenes experts. Here, we extend our sincerest gratitude to the following key leaders and mentors:Mr. Shan Min, Secretary-General of the Xi'an Pharmaceutical Association、Ms. Chen Ping, Secretary-General of the Shaanxi Provincial Society for Research and Development of Traditional Chinese Medicine Science and Technology、Mr. Zheng Fangye from Xi'an Damo Pharmaceutical Co., Ltd., andMr. Liu Haijing, Former Dean of the Shaanxi Provincial Institute for Food and Drug Control。
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