The “Regulations on the Protection of Traditional Chinese Medicine Varieties” has been promulgated and implemented for 30 years, and this article briefly summarizes the background of the establishment of the Chinese medicine protection system, the formation process of the system, and the effectiveness of the five aspects of rectifying the order, improving reputation, economic benefits, medical security and quality improvement, as well as the problems and challenges existing in the implementation process, so as to provide materials for the revision and improvement of the protection system of traditional Chinese medicine varieties.

According to the problems found during the implementation of the protection system of traditional Chinese medicine varieties, adhering to the problem and clinical value as the guidance, from the aspects of highlighting the problem-oriented, registration management convergence and people-centered, the overall and specific ideas of revision and improvement of the system were put forward, and specific suggestions were proposed from ten aspects, such as the scope of protection, the connection with the patent system, the incentive mechanism, the withdrawal mechanism, and the connection with the registration procedures.

The TCM products protection system is a socialist legal system with Chinese characteristics for the government intervention and management on economic activities in specific fields. In December 2022, the “Regulations on Protection of Traditional Chinese Medicinal Products (Revised Draft for Soliciting Opinions)” proposed the institutional design of the exclusive protection for TCM products, which conforms to the innovative laws of TCM, has historical inevitability and fairness for regulating the market rationally. Only by correctly understanding the innovative laws of TCM can the necessity and rationality of the system itself be correctly evaluated. Improving the quality of TCM products is an abandoning process. The rules on cultural inheritance and innovation should be followed, every progress must be affirmed and encouraged. The innovation capability of the TCM industry is the foundation of modern enterprise market competition. Market management requires targeted and effective market incentive policies. Confronting the legal needs of TCM enterprises for business environment and establishing an exclusive protection mechanism are conducive for enterprises to participate in domestic and international market competition. The content of this article only represents the author's viewpoint and does not represent the author's unit's viewpoint or position.

OBJECTIVE To identify the stakeholders involvedin the protection policy of Chinese herbal decoction pieces, consider the interest demands of stakeholders, and promote the implementation of theprotection policy of Chinese herbal decoction pieces with balanced interests. METHODS Based on the stakeholder theory, this paper identifies 12 stakeholders that may be involved in the protection policy of Chinese herbal decoction pieces through literature research, and uses the expert consultation method to evaluate its influence according to the stakeholder impact index formula. RESULTS According to the stakeholder impact index results of the above stakeholders,determine the “National drug administration department, the production enterprises of Chinese herbal decoction pieces, provincial drug administration department, Chinese patent medicine production enterprises and medical institutions” as its core stakeholders. Furthermore, the main interest demands of each core stakeholder are obtained through qualitative interview analysis. NMPA is concerned about the continuous improvement of the quality of Chinese herbal decoction pieces, TCM decoction pieces production enterprises are concerned about the specific protection methods of policies, provincial drug regulatory departments are concerned about local regulatory performance, and manufacturers of Chinese patent medicines, medical institutions are concerned about the price and market demand of protected TCM decoction pieces. CONCLUSION Some countermeasures and suggestions are put forward for the formulation of the protection policy of Chinese herbal decoction pieces.such as the drug regulatory department is the main body of the policy formulation and supervision and implementation, establishing protection conditions should consider the relationship between the TCM decoction piece industry and the upstream and downstream stakeholders and protection methods should take into account the compatibility with current medical and health policies, so as to provide reference for the formulation of the protection policy of Chinese herbal decoction pieces.