1985年7月1日，卫生部颁布实施了《新药审批办法》，使我国新药审批工作纳入了法制化管理的轨道。十年来，我市坚持依法审药，严把初审关，取得了一定成效。一我们的做法《新药审批办法》规定，新药由卫生部集中统一审批，各省（市）卫生厅（局）为初审单位。这一改革措施，强 On July 1, 1985, the Ministry of Health promulgated and implemented the Measures for the Examination and Approval of New Drugs, bringing the approval of new drugs into the track of legalized management. In the past ten years, our city insisted on trial of drugs according to law and strictly controlled the preliminary examination and achieved some success. A our approach “new drug approval approach” provides that the new drug by the Ministry of Health centralized examination and approval, provincial (city) Health Department (Bureau) as the first instance unit. This reform measure is strong