Recombinant Humanized Collagen is established as a standard in the medical device industry, the Guidelines on Recombinant Collagen Biomaterial …… Chinese regulators attach great importance to the innovative development of the recombinant collagen industry. Since 2021, Chinese regulatory authorities have successively issued a series of documents to divide a clear sector for the collagen industry.
On April 22, Beijing time (the following occurrence times are Beijing time), the National Medical Products Administration issued a notice on the establishment of the industry standard for medical devices Recombinant Humanized Collagen. The notice said that to encourage the R&D and the innovation of new biomaterials of the recombinant humanized collagen and promote the high-quality development of China’s medical device industry, combined with the need for industrial development and regulatory work, after research. The National Medical Products Administration approved the revision of standards on the Recombinant Humanized Collagen in the medical device industry.
Collagen is an important structural protein in human and animal tissues, widely present in tendons, ligaments, cartilage, skin and other connective tissues, is the most abundant and widely distributed functional protein in mammals.
In recent years, with China’s emphasis on the field of biomaterials, collagen basic research and application development have attracted much attention. The innovative medical products based on human-derived recombinant collagen present huge market potential. According to GrandView Research, China reached about $972 million in the size of the collagen market in 2019, accounting for 6.40% of the global market. It is estimated that China’s collagen market will reach $3.067 billion in 2027, accounting for 6.96% of the global market. The overall market size of collagen in China is growing faster than that of the world.
China’s research and industrialization in the field of recombinant collagen is at the forefront of the world, and has initially achieved large-scale production and has been applied to many fields such as medical devices and cosmetics. It is worth noting that the naming principle of some listed product names in China is not uniform, such as the terms used in product names such as “humanoid collagen”, “yeast recombinant collagen”, “medical recombinant human collagen”, “medical type III collagen” and so on.
On March 15, 2021, the National Medical Products Administration issued the Guidelines for the Naming of Recombinant Collagen Biomaterials, which is used to guide the naming of recombinant collagen biomaterials in the field of medical devices in China. As a result, recombinant collagen is divided into three categories: recombinant human collagen, recombinant humanized collagen, and recombinant collagen, which further standardizes the naming of recombinant collagen biomaterials in China.
Recombinant collagen has good biological properties, degradability, and other characteristics, as a raw material used in medicine, cosmetics, and other fields. Are our skincare products containing recombinant collagen a medical device or a cosmetic product? As more and more recombinant collagen products are available, the classification and definition of medical products containing recombinant collagen have attracted public attention.
On April 15, 2021, the National Medical Products Administration issued the Principles for the Classification and Definition of Recombinant Collagen Medical Products, which clarifies the management attributes and management category determination basis for recombinant collagen medical products and provides guiding documents for the classification and definition of recombinant collagen medical products and the compliance of innovative product research and development.
On January 18, 2022, the National Medical Products Administration released the industry standard of YY/T 1849-2022 Recombinant Collagen. The standard stipulates the quality control requirements, testing indicators, and detection methods of recombinant collagen in China, applying to the quality control of recombinant collagen as the raw material of medical devices in China, which will be officially implemented on August 1, 2022.
With the promulgation and landing of new regulations on China’s recombinant collagen industry one by one, it means that China has tightened the policy supervision of the “recombinant collagen” market with many unqualified commodities and enterprises in the market being doomed to disappear.