The purpose and significance of variety protection of traditional Chinese medicine;
Traditional Chinese medicine is an important part of traditional medicine in China and a precious heritage of Chinese culture. There are more than 4,000 traditional varieties with stable quality and definite curative effect in China. From 1985 to1by the end of 1996, there were 630 new Chinese medicine approved by the Ministry of Health. However, there are no necessary protective measures for traditional Chinese medicine. Therefore, the Ministry of Health put forward the protection of traditional Chinese medicine.
Purpose and significance
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, so as to improve the quality of varieties of traditional Chinese medicine, protect the legitimate rights and interests of Chinese medicine production enterprises and promote the development of traditional Chinese medicine.
The promulgation and implementation of the Regulations on the Protection of Varieties of Traditional Chinese Medicine marks that the research, production and management of traditional Chinese medicine in China have embarked on the legal track; It is of great significance to protect the famous products of traditional Chinese medicine, protect the intellectual property rights of scientific research and production of traditional Chinese medicine, improve the quality and reputation of traditional Chinese medicine, promote the scientific and technological progress of traditional Chinese medicine pharmaceutical enterprises, develop clinical safe and effective new drugs, and push traditional Chinese medicine to the international pharmaceutical market.
The scope of application and management departments of the Regulations on the Protection of Traditional Chinese Medicine Varieties
Varieties of traditional Chinese medicines suitable for production and manufacture in China, including proprietary Chinese medicines, natural medicine extracts and their preparations, and artificial products of traditional Chinese medicines, and varieties of traditional Chinese medicines applying for patents shall be handled in accordance with the provisions of the Patent Law, and these Regulations shall not apply. The regulatory authorities and the State Drug Administration are responsible for the supervision and administration of the protection of traditional Chinese medicines throughout the country. State administration of traditional chinese medicine is responsible for the overall management of the national protection of traditional Chinese medicine.
The State Drug Supervision and Administration Department has set up the National Evaluation Committee for the Protection of Traditional Chinese Medicine Varieties, which is a professional technical evaluation and consultation institution for the examination and approval of protected varieties of traditional Chinese medicine. It has an office under the leadership of the State Pharmaceutical Products Administration and is responsible for daily management and coordination.