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为提高中药品种质量,保护中药生产企业的合法权益,促进中药事业发展,国务院最近颁布《中药品种保护条例》,自1993年1月起施行。《条例》指出,国家鼓励研制开发临床有效的中药品种,对质量稳定、疗效确切的中药品种实行分级保护制度。批准保护的中药品种,由国务院卫生行政部门发给《中药保护品种证书》。申请一级保护的中药品种条件包括对特定疾病有特殊疗效,相当于国家一级保护野生药材物种的人工制成品,
In order to improve the quality of Chinese medicine varieties, protect the legitimate rights and interests of traditional Chinese medicine production enterprises, and promote the development of traditional Chinese medicine, the State Council recently promulgated the Regulations on the Protection of Chinese Medicinal Plant Varieties, which has been in effect since January 1993. The “Regulations” pointed out that the State encourages the research and development of clinically effective varieties of traditional Chinese medicine, and implements a grading protection system for Chinese medicine varieties with stable quality and effective curative effect. The varieties of Chinese medicines approved for protection shall be issued by the State Council’s health administrative department to the “Certificate for the Protection of Chinese Medicinal Products”. The conditions of Chinese medicine varieties applied for protection at Grade I include special effects on specific diseases, equivalent to artificial products manufactured at the national level to protect wild medicinal species.