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《新药审批办法》颁布、实施后,卫生部又发布了《关于新药审批管理的若干补充规定》。在此期间,卫生部药政局和卫生部药品审评办公室(下称药审办)在一些地区举办了新药审评研讨班,因此,目前各初审单位和研制单位的新药申报资料已有较大改进。为了加强新药审批工作的管理,提高审批水平和工作效率,1989年卫生部对新药审批的机构和工作程序进行了调整和改革,由药审办归口负责办理新药审批的各项工作。将新药的审批分为初审和复审两个阶段,中、西新药的初审由省、自
After the promulgation and implementation of the Measures for Examination and Approval of New Drugs, the Ministry of Public Health promulgated certain Supplementary Provisions on the Examination and Approval of New Drugs. During this period, the Pharmaceutical Administration of the Ministry of Health and the Drug Evaluation Office of the Ministry of Health (hereinafter referred to as the Drug Accreditation Office) held seminars on drug evaluation in some areas. As a result, there is a large amount of new drug application information in all first trial units and research institutes Improve. In order to strengthen the management of the examination and approval of new drugs and improve the level of examination and approval and the efficiency of work, the Ministry of Health conducted adjustments and reforms in the institutions and procedures for the approval of new drugs in 1989, and the departments of drug audits are in charge of handling the examination and approval of new drugs. The approval of new drugs is divided into two stages of the first instance and review, the first trial of new drugs in China by the provinces, since