The 8th International Conference on Medicinal Excipients in China, co hosted by the International Association of Medicinal Excipients (China) and Reed Sinopharm, and co organized by the International Alliance of Medicinal Excipients Associations, was successfully held in Xi'an on October 16-17, 2024. More than ten domestic and foreign experts from the National Pharmacopoeia Commission, Hunan Provincial Institute of Drug Inspection and Testing, East China University of Science and Technology, as well as the International Pharmaceutical excipients Association Federation (IPEC Federation), the United States Pharmacopeia Commission (USP), the European Medicines Quality Management Agency (EDQM), and others gave wonderful speeches on 15 hot topics. Representatives from regulatory authorities, domestic and foreign pharmaceutical companies, and pharmaceutical excipient production and operation enterprises attended the meeting.

Former IPEC China Chairman Song Qianqian, IPEC China Vice Chairman Wang Suming, and former IPEC China Director Tao Zhengyu respectively presided over the meeting.

The conference has three sessions: Session A: The latest developments in global pharmaceutical excipient regulations and pharmacopoeias, Session B: Quality and safety of pharmaceutical excipients, and Session C: The latest hot topics in the pharmaceutical excipient industry.

Session A mainly focuses on the latest developments in global pharmaceutical excipient regulations and pharmacopoeia, providing participants with a comprehensive understanding of the development of pharmaceutical excipient regulations and pharmacopoeia from the perspectives of international organizations, domestic pharmacopoeia institutions, and enterprise technology. In this session, Kevin Hughes from the International Pharmaceutical Excipients Alliance introduced the goals and industry trends of the International Pharmaceutical Excipients Association, as well as the impact of the latest global regulations on pharmaceutical excipients, and introduced the development trends at the international level to the participants. Teacher Chen Lei from the National Pharmacopoeia Committee introduced the coordination and innovation of the 2025 edition of the Chinese Pharmacopoeia for pharmaceutical excipients standards, and shared the development direction of the Chinese Pharmacopoeia. In addition, Professor Bi Yong from Anhui Shanhe Medicinal Excipients Co., Ltd. shared the development and quality control of co processed excipients, enriching the content of the event from the perspective of enterprise practice.

Session B focuses on the quality and safety issues of pharmaceutical excipients, and deeply explores the quality and safety of pharmaceutical excipients, covering pharmacopoeia standards, supply chain safety, regulatory considerations for specific excipients, and regulation of emerging nanomaterials in multiple countries and regions. It provides multidimensional thinking to ensure the quality and safety of pharmaceutical excipients. In this session, Dr. Ling Xiao from the United States Pharmacopeia introduced the Action Plan and updates of the USP Pharmaceutical Excipients Standards. Adrian Bones from the International Pharmaceutical Excipients Alliance shared the position paper on supply chain security and the International Pharmaceutical Excipients Alliance. Teacher Xu Xiaofeng from Shanghai Kalekang Coating Technology Co., Ltd. discussed the global regulatory considerations for film coating premix. Dr. Cai Lirong from Hunan Provincial Institute of Drug Inspection and Testing analyzed the differences in elemental impurities of pharmaceutical excipients in the European, American, and Japanese Pharmacopoeias and their implications for the Chinese Pharmacopoeia. Anne Garnier from the European Medicines Quality Management Agency (EDQM) introduced the current hotspots and trends of the European Pharmacopoeia and EDQM. Kevin Hughes also explained the regulatory status and public opinion on nanomaterials.

Session C focuses on the latest hot issues in the pharmaceutical excipient industry, closely following the latest hot topics in the pharmaceutical excipient industry, covering microbial contamination control, application standard research, biological product excipient research, and registration data management. It shares cutting-edge information and provides practical references for participants. In this session, Professor Sheng Jinfang from the former Shaanxi Provincial Drug Technical Evaluation Center introduced the application of water activity in controlling microbial contamination of drugs. Teacher Wang from the Drug Evaluation Center of the former National Medical Products Administration discussed the microbiological limit declaration standards for non sterile chemical drugs and raw materials. Teacher Dai Hong from the former Beijing Institute for Drug Control and Research shared the research progress on pharmaceutical excipients in biological products. Professor Li Suxia from East China University of Science and Technology explained the risk management of raw materials for biological products. Mr. Li Yinbo from Shenyang Xizi Biomedical Technology Service Co., Ltd. introduced the preparation, electronic submission, and related review system of registration materials for pharmaceutical excipients.

The 8th International Pharmaceutical Excipients China Conference successfully established a communication platform for exchange and cooperation in the pharmaceutical excipients industry, promoting the development and dialogue of the domestic and international pharmaceutical excipients industry. Enhanced information communication and exchange among regulatory authorities, research institutes, industry associations, pharmaceutical manufacturers, and pharmaceutical excipient companies. At the same time, the conference was held concurrently with the 91st API exhibition, creating a comprehensive communication platform for upstream and downstream enterprises, and providing an opportunity for professionals to exchange and share technology. The professional, cutting-edge and practical topic setting of the conference, as well as the close technical exchange opportunities with upstream and downstream industries, have received unanimous praise from the attending representatives.

Click on the attachment to download the conference materials. Please refer to the email from IPEC China Secretariat for the file decompression password