The purpose and significance of variety protection of traditional Chinese medicine;
1. The state encourages the research and development of clinically effective varieties of traditional Chinese medicine, and implements a graded protection system for varieties of traditional Chinese medicine with stable quality and definite curative effect.
2. Objective: To improve the quality of Chinese medicine varieties, protect the legitimate rights and interests of Chinese medicine production enterprises, and promote the development of Chinese medicine.
Suitable for Chinese traditional medicine varieties, including Chinese patent medicines, natural medicine extracts and their preparations, and Chinese traditional medicine artificial products. The varieties of Chinese medicines applying for patents shall be handled in accordance with the provisions of the Patent Law, and these Regulations shall not apply. Except for the varieties of traditional Chinese medicine for which patents are applied. The State Food and Drug Administration of the United States is responsible for the supervision and management of the national protection of traditional Chinese medicine varieties, and state administration of traditional chinese medicine cooperates with the management of the national protection of traditional Chinese medicine varieties. The first imported medicinal materials refer to the imported medicinal materials from different countries (regions), different applicants and different medicinal materials. After obtaining the approval documents of imported medicinal materials, file with the port drug supervision and administration department; Non-first-time import shall be directly filed with the port drug supervision and administration department, and the non-first-time import of medicinal materials shall be subject to catalogue management, and the specific catalogue shall be formulated and adjusted by the State Pharmaceutical Products Supervision and Administration Bureau.
legal ground
"Regulations on the Protection of Varieties of Traditional Chinese Medicine" Article 2 These Regulations apply to varieties of traditional Chinese medicine produced and manufactured in China, including proprietary Chinese medicines, natural drug extracts and their preparations, and artificial products of traditional Chinese medicine.
The varieties of Chinese medicines applying for patents shall be handled in accordance with the provisions of the Patent Law, and these Regulations shall not apply.
Regulations on the Protection of Varieties of Traditional Chinese Medicine Article 3 The State encourages the research and development of clinically effective varieties of traditional Chinese medicine, and implements a graded protection system for varieties of traditional Chinese medicine with stable quality and definite curative effect.
"Regulations on the Protection of Traditional Chinese Medicine Varieties" Article 4 The health administrative department of the State Council is responsible for the supervision and management of the protection of traditional Chinese medicine varieties throughout the country. The state department in charge of the production and operation of traditional Chinese medicine shall cooperate in the protection and management of traditional Chinese medicine varieties throughout the country.