Recently, regarding the registration of Chinese medicine, safety issues, the State Drug Administration comprehensive department issued "Chinese medicine registration management special provisions (draft for comment)" (hereinafter referred to as "special provisions"). The regulations have a total of 12 chapters and 87 articles. Involved in the registration of Chinese medicine classification and marketing approval; human use of empirical evidence of rational application; innovative drugs; improved new drugs; ancient classical prescriptions of Chinese medicine compound preparations; the same name and prescription drugs; post-marketing changes; drug registration standards; drug names and instructions.

It is worth mentioning that the provision proposed that, Chinese medicine instructions [contraindications], [adverse reactions], [precautions] in any one of the application for re-registration of drugs is still "unclear", will not be re-registered. The industry believes that if the regulation is implemented, the Chinese medicine manual of this matter will involve a large number of proprietary Chinese medicine enterprises.

For a long time, the revision of the Chinese medicine manual will have a considerable direct impact on pharmaceutical companies. Some pCms involve a wide range of products, and the revised instructions will directly affect hundreds of pharmaceutical companies. Under this background, it may cause a major reshuffle in the Chinese medicine market.

Regarding this, industry analysis believes that the companies need to do a series of evidence-based research to make Chinese medicine manual specific, standardized if the companies cannot survive after Chinese medicine adverse reactions "not yet clear". In fact, the standardized development of Chinese medicine has been one of the key concerns of the national development of the Chinese medicine industry, and the relevant departments are frequently issuing policies to strictly regulate and promote the development of the Chinese medicine industry towards standardization and high quality in all aspects of production, processing and storage.

Take production as an example, Chinese herbal medicines are prone to errors in the production process and quality control. Therefore, in recent years, many departments in China have jointly issued a series of documents, such as the "national production base construction planning of authentic Chinese medicinal materials" and "quality management standards for the production of Chinese medicinal materials", to jointly strengthen the source management. In addition, a series of policies have been introduced to increase the penalties and costs for enterprises that violate the production.

Under such circumstances, the only solution is to adhere to compliance for the relevant enterprises. In fact, in order to control the quality of Chinese medicine from the source, promote the development of integrated processing and concoction of Chinese herbal medicines at origin, improve the market competitiveness of the Chinese herbal medicine industry, promote the high-quality development of the Chinese medicine industry, and improve the quality of Chinese herbal medicines and Chinese medicine tablets, many enterprises have now started to process Chinese herbal medicines at procurement origin in order to promote the work of processing at origin towards standardization and standardization, etc.

It is worth mentioning that, under the background of digital change that has swept through the TCM industry, many TCM enterprises are also vigorously accelerating transformation and upgrading with the help of digital technology and equipment to promote the high-quality development of pharmaceuticals. For example, Hanvon Pharmaceuticals is continuously improving the quality of its products as well as expanding its business scale by introducing digital TCM production lines. It is reported that Hanvon Pharmaceuticals has abandoned the traditional labor-intensive production methods and introduced a set of continuous modern Chinese medicine production equipment. This fully integrated automated production plant not only improves production efficiency and product quality, but also further empowers the company's development.

In addition, Yunnan Baiyao is also using 5G, industrial internet, big data, artificial intelligence, block chain and other technologies to create a "digital panax pseudoginseng industry platform", helping Yunnan panax pseudoginseng industry to embark on the transformation and upgrading of standardization and standardization.

Currently, the quality of Chinese medicine products, including Chinese medicine herbal pieces, has been significantly improved under the background of multiple measures. The 2021 National Chinese Medicine Regulatory Blue Book shows that the overall qualification rate of Chinese medicine herbal pieces has increased from 77.7% to 98.4% from 2016 to 2021 under the significant improvement and enhancement of raw material herbal control, production process and product quality of Chinese medicine tablets in recent years.

Industry analysis believes that, a series of national to local policies are supporting the high-quality development of the Chinese medicine industry and the continuous tightening of drug safety supervision. The future demand and technical requirements for Chinese medicine processing equipment will also be further increased. In this context, for the relevant enterprises, it is urgent to research new processes and new technologies to make the equipment more efficient and intelligent to further improve the quality and safety of Chinese medicine.

Source: Pharma.com