Xinhua News Agency, Beijing, November 9
Regulations on the Protection of Traditional Chinese Medicine Knowledge
Article 1 In order to protect traditional knowledge of traditional Chinese medicine, promote the inheritance and development of traditional knowledge of traditional Chinese medicine, and promote traditional Chinese medicine culture, these regulations are formulated in accordance with the "Traditional Chinese Medicine Law of the People's Republic of China".
Article 2 The term “traditional knowledge of traditional Chinese medicine” as mentioned in these Regulations refers to the theories, technical methods and related manifestations of traditional Chinese medicine formed based on the long-term practice accumulation and inheritance and development of the Chinese nation from generation to generation, including:
(1) Traditional theories and technical methods of prevention, health care, diagnosis, treatment and rehabilitation of traditional Chinese medicine;
(2) Classic and proven prescriptions of traditional Chinese medicine;
(3) Traditional technologies for the selection, planting, breeding, collection, and identification of Chinese medicinal materials, traditional technologies and techniques for processing Chinese medicinal pieces, and preparing Chinese medicinal preparations;
(4) Ancient Chinese medicine literature, traditional marks and symbols unique to Chinese medicine;
(5) Other traditional knowledge of traditional Chinese medicine.
Article 3 The protection of traditional knowledge of traditional Chinese medicine should follow the development laws of traditional Chinese medicine, insist on inheriting the essence, keeping integrity and innovation, and adhere to the priority of protection and the combination of protection and utilization.
When carrying out activities to protect traditional knowledge of traditional Chinese medicine, laws and administrative regulations must be observed, and national interests, social public interests, and the legitimate rights and interests of others must not be harmed.
Article 4 The competent department of traditional Chinese medicine under the State Council is responsible for the protection of traditional knowledge of traditional Chinese medicine nationwide.
The competent departments of traditional Chinese medicine of local people's governments at or above the county level are responsible for the protection of traditional knowledge of traditional Chinese medicine within their respective administrative regions.
Other relevant departments of the people's governments at or above the county level are responsible for work related to the protection of traditional knowledge of traditional Chinese medicine within the scope of their respective responsibilities.
Article 5 The competent department of traditional Chinese medicine under the State Council and other relevant departments under the State Council shall establish an information sharing mechanism related to traditional knowledge of traditional Chinese medicine to strengthen work coordination.
Article 6 The competent departments of traditional Chinese medicine under the people's governments at or above the provincial level shall incorporate the protection of traditional Chinese medicine knowledge into relevant plans, strengthen the inheritance, dissemination, promotion and application of traditional Chinese medicine knowledge, and scientific and technological research, and provide necessary support.
The competent departments of traditional Chinese medicine of people's governments at or above the county level encourage and guide social forces to participate in the protection of traditional knowledge of traditional Chinese medicine through donations, volunteer services, etc.
Article 7 The state encourages and supports news media, public cultural institutions, etc. to carry out activities such as publicity, display, and experience of traditional knowledge of traditional Chinese medicine according to their respective business scopes.
When carrying out activities such as promoting, displaying, and experiencing traditional Chinese medicine knowledge, relevant national regulations must be observed. False or exaggerated publicity is not allowed, and illegitimate gains are not allowed.
Article 8 The state supports foreign exchanges and cooperation of traditional Chinese medicine knowledge and promotes the international dissemination and application of traditional Chinese medicine knowledge.
The management of foreign investment, outbound investment, and technology export involving traditional knowledge of traditional Chinese medicine shall be implemented in accordance with the Foreign Investment Law of the People's Republic of China, the Foreign Trade Law of the People's Republic of China, the Regulations of the State Council on Foreign Investment, the Regulations of the People's Republic of China on the Administration of Technology Import and Export, and other laws, administrative regulations, and relevant national regulations.
Article 9 The competent department of traditional Chinese medicine under the State Council shall work with other relevant departments under the State Council to strengthen the training of talents with traditional knowledge of traditional Chinese medicine.
Organizations and individuals that have made outstanding contributions to the protection of traditional knowledge of traditional Chinese medicine will be rewarded in accordance with relevant national regulations.
Article 10 If the protection of traditional knowledge of traditional Chinese medicine involves state secrets, work secrets, business secrets, personal privacy and personal information, the provisions of relevant laws and administrative regulations shall be observed.
Article 11 The competent department of traditional Chinese medicine under the State Council shall strengthen the overall planning and coordination of the collection and selection of ancient Chinese medicine literature and the investigation of traditional knowledge of traditional Chinese medicine.
Article 12 The competent department of traditional Chinese medicine under the State Council shall establish a protection database of traditional Chinese medicine knowledge and implement classified management of the traditional Chinese medicine knowledge included in the protection database. Specific measures for the management of protected databases shall be formulated by the competent department of traditional Chinese medicine under the State Council.
Article 13 The competent department of traditional Chinese medicine under the State Council shall organize professional institutions to organize and select ancient Chinese medicine documents. The selected ancient Chinese medicine documents and the traditional knowledge of traditional Chinese medicine recorded in ancient books shall be included in the protection database after being identified by the competent department of traditional Chinese medicine under the State Council.
Article 14 The competent department of traditional Chinese medicine of the provincial people's government is responsible for organizing and carrying out the investigation of traditional Chinese medicine knowledge within its own administrative region. The traditional knowledge of traditional Chinese medicine discovered during the investigation will be included in the protection database after being identified by the competent department of traditional Chinese medicine of the State Council.
The investigation of traditional knowledge of traditional Chinese medicine can involve the participation of medical institutions, universities, scientific research institutions, enterprises, societies, industry associations and chambers of commerce.
Overseas organizations and individuals are not allowed to conduct investigations into traditional knowledge of traditional Chinese medicine in my country.
Specific methods for the investigation of traditional knowledge of traditional Chinese medicine shall be formulated by the competent department of traditional Chinese medicine under the State Council.
Article 15 When conducting an investigation of traditional knowledge of traditional Chinese medicine, the consent of the investigation subjects shall be obtained, their customs and habits shall be respected, and their legitimate rights and interests shall not be harmed; the physical objects and materials obtained during the investigation shall be properly preserved to prevent damage or loss.
For traditional Chinese medicine knowledge that is on the verge of disappearing discovered through investigation or other means, the competent department of traditional Chinese medicine of the provincial people's government shall immediately record it, collect relevant physical objects and materials, or take other rescue and protection measures.
Article 16 The state encourages organizations and individuals to declare their traditional knowledge of traditional Chinese medicine to the local provincial people’s government’s competent department of traditional Chinese medicine. The declared traditional knowledge of traditional Chinese medicine shall be included in the protection database after preliminary verification by the provincial people’s government’s competent department of traditional Chinese medicine and identification by the competent department of traditional Chinese medicine under the State Council.
Article 17 The competent department of traditional Chinese medicine under the State Council shall publish information related to traditional knowledge of traditional Chinese medicine included in the protected database.
The competent department of traditional Chinese medicine under the State Council, together with the culture and tourism departments of the State Council, uses digital technology to collect traditional knowledge of traditional Chinese medicine to facilitate preservation and use and facilitate public access.
Article 18 Holders of traditional Chinese medicine knowledge have the right to inherit and use the traditional Chinese medicine knowledge they hold, and have the rights to informed consent and benefit sharing for others to acquire and use the traditional Chinese medicine knowledge they hold.
The state supports the rational use of traditional knowledge of traditional Chinese medicine, such as traditional theories, technical methods and classic prescriptions recorded in ancient Chinese medicine books, which are in the public domain and can be openly accessed, and the competent department of traditional Chinese medicine under the State Council performs the responsibilities of the holder. Specific measures shall be formulated by the competent department of traditional Chinese medicine under the State Council.
Article 19 The competent department of traditional Chinese medicine under the State Council shall establish a protection list of traditional Chinese medicine knowledge and include representative, unique and important traditional knowledge of traditional Chinese medicine in the protection database in the protection list. Specific measures for the management of protected lists shall be formulated by the competent department of traditional Chinese medicine under the State Council.
Article 20 The competent department of traditional Chinese medicine under the State Council shall establish a protection list review expert group to select traditional knowledge of traditional Chinese medicine to be included in the protection list from the protection database. The competent department of traditional Chinese medicine under the State Council will publicize the selected traditional knowledge of traditional Chinese medicine and issue a protection list based on the results of the publicity.
The competent department of traditional Chinese medicine of the provincial people's government may recommend to the competent department of traditional Chinese medicine of the State Council the traditional knowledge of traditional Chinese medicine to be included in the protected list.
If the traditional Chinese medicine knowledge included in the protection list no longer meets the conditions, the competent department of traditional Chinese medicine under the State Council will organize a review expert group to identify it and remove it, and announce it to the public in a timely manner.
Article 21 Local people's governments at or above the county level may provide necessary support for the inheritance and dissemination of traditional Chinese medicine knowledge listed on the protection list based on actual conditions.
Article 22 The culture and tourism department of the State Council shall work with the cultural relics, traditional Chinese medicine and other competent departments of the State Council to strengthen the protection, restoration, rational utilization and inheritance of ancient Chinese medicine books listed on the protection list.
Article 23 The competent departments of traditional Chinese medicine of the people's governments at or above the county level shall, in accordance with the needs for the protection of traditional Chinese medicine knowledge and rely on high-level medical institutions, promote the promotion and application of traditional Chinese medicine knowledge included in the protected list through the following methods:
(1) Collect and organize relevant physical objects and information;
(2) Carry out clinical applications;
(3) Carry out applied research and improve the standardization and standardization level of clinical application;
(4) Carry out teacher-to-teacher education and training to cultivate future talents;
(5) Organize technical method demonstrations, academic seminars and exchanges and other activities.
Article 24 The competent department of traditional Chinese medicine under the State Council, together with the industry and information technology, drug supervision and administration and other departments of the State Council, shall rely on traditional Chinese medicine piece production enterprises, medical institutions, etc. to conduct research, promotion and application of traditional technologies and techniques for processing traditional Chinese medicine pieces that are included in the protected list, and support the application of traditional techniques and techniques for processing traditional Chinese medicine pieces to improve the quality level of traditional Chinese medicine pieces.
Article 25 The competent department of traditional Chinese medicine under the State Council, in conjunction with the agriculture and rural affairs, drug supervision and administration and other departments of the State Council, shall promote and apply traditional technologies for the selection, planting and breeding, collection and identification of traditional Chinese medicine varieties listed on the protected list.
Article 26 The state encourages and supports the use of traditional Chinese medicine research methods and modern science and technology to carry out research on traditional Chinese medicine knowledge, encourages medical institutions, universities, scientific research institutions, enterprises, societies, industry associations and chambers of commerce, etc. to cooperate in research, strengthen research on basic theories, mechanisms of action, clinical applications, etc., and promote the inheritance and innovation of traditional Chinese medicine theories and technical methods.
Article 27 The competent departments of traditional Chinese medicine under the people's governments at or above the provincial level shall, in accordance with the needs for the protection of traditional Chinese medicine knowledge, organize universities, scientific research institutions, etc. to adopt the following methods to carry out scientific and technological research on traditional Chinese medicine knowledge included in the protected list:
(1) Collect and organize relevant physical objects and information;
(2) Carry out theoretical and technical method tracing and key information research;
(3) Carry out development, utilization and transformation of results.
Article 28 If the competent departments of traditional Chinese medicine and other relevant departments of the people's governments at or above the county level fail to perform their duties of protecting traditional knowledge of traditional Chinese medicine in accordance with the provisions of these Regulations, the people's government at the same level or the relevant departments of the people's government at the next higher level shall order corrections within a time limit; if the circumstances are serious, the responsible leaders and directly responsible personnel shall be punished in accordance with the law.
Article 29 If any investigation of traditional knowledge of traditional Chinese medicine is carried out in violation of the provisions of paragraph 3 of Article 14 of these Regulations, the competent department of traditional Chinese medicine of the people's government at or above the county level shall order the person to stop the illegal behavior, give a warning, confiscate the illegal gains and the physical objects and materials obtained during the investigation, and may impose a fine of not less than 50,000 yuan but not more than 500,000 yuan.
Article 30 Anyone who violates the provisions of these Regulations and causes damage to holders of traditional knowledge of traditional Chinese medicine shall bear civil liability in accordance with the law; if it constitutes a crime, criminal liability shall be pursued in accordance with the law.
Article 31 If traditional knowledge of traditional Chinese medicine is a cultural relic or intangible cultural heritage item, it shall also be protected in accordance with the relevant provisions of the Cultural Relics Protection Law of the People's Republic of China and the Intangible Cultural Heritage Law of the People's Republic of China.
Article 32 These regulations will come into effect on January 1, 2027.
