国家药品监督管理局和中华人民共和国卫生部于2000年4月4日联合发出《枸橼酸西地那非管理暂行规定》,内容如下: 枸橼酸西地那非制剂是用于治疗男性性功能障碍的处方药。为保证医疗使用,防止滥用,必须对其生产、经营及使用进行严格管理。为此,特作如下规定: 一、经批准生产枸橼酸西地那非原料及其制剂的生产企业,应于每年12月底之前将本年度该产品的生产情况报国家药品监督管理局备案。 二、生产枸橼酸西地那非制剂的企业须按特殊药品渠道经营,即将产品售给具有特殊药品经营权的药品经营 On April 4, 2000, the State Drug Administration and the Ministry of Health of the People’s Republic of China jointly issued the Interim Provisions on Sildenafil Citrate Management, which read as follows: The sildenafil citrate preparation is used to treat male sex Dysfunctional prescription drugs. In order to ensure medical use and prevent abuse, we must strictly control its production, operation and use. For this purpose, the following special provisions: First, the approved production of sildenafil citrate raw materials and their preparations of the manufacturing enterprises should be in the end of December each year the production of the product information to the State Drug Administration for the record. Second, the enterprises producing sildenafil citrate preparations shall operate according to the channels of special drugs, and the products are to be sold to the pharmaceutical manufacturers that have the right to operate special drugs