Editor Note: With the wide application of collagen products in the field of food and cosmetics and the rapid growth of industrialization, the application of collagen in the medical field has also attracted much attention in recent years. Large and medium-sized enterprises have intervened in the research and development of medical products, and the industrialization process has developed rapidly. The structure, purity and other properties of collagen directly affect the quality and safety of its intended medical applications. However, there is no systematic collagen product characterization and quality evaluation system, and the development of relevant standards and guidances lag far behind the pace of industrial development. Methods:For this purpose, the National Institutes for Food and Drug Control (NIFDC) has organized and drafted a technical consensus on the characterization and quality evaluation of collagen products used for medical application on the basis of a large number of investigations on relevant standards and guidances at domestic and abroad. After the first round of opened solicit opinions, a special academic forum was organized on June 28, 2019. A preliminary consensus was reached with 180 experts and delegates participating in the forum. The controversial part was further revised and improved. In July, 2019, a second round of opened solicit opinions was conducted. After further modification and improvement, the final draft was formed. Results:This technical consensus gives the background and significance, scope of application, basic terms and definitions related to collagen, performance indexes and reference evaluation methods of collagen products, as well as quality control and risk management of collagen products. The purpose of this technical consensus is to provide reference for research and development, manufacture, quality control, testing and evaluation of medical collagen products and technical review. Conclusion: Standardized methods and reference materials are indispensable tools and means for strict quality control. The NIFDC is establishing a series of methods and standards for characterization and assessment of collagen and is developing collagen protein and collagen characteristic peptide reference materials for different types (such as type I, type II and type III, etc.) and different spices of collagen (such as from bovine, pig and human, etc.). Among them, the bovine type I collagen reference material will be on the market in 2019; the bovine type II collagen reference material is expected to be on the market in 2020. |