在新药审批程序中首先需经省(市)卫生部门初审后将申请表和资料上报给卫生部药政局一份,给卫生部药品审评办公室(以下简称“药审办”)三份,经“药审办”再审后,认为基本符合要求者,根据所报新药类别、种类,通知申请单位再上报所需资料的份数,由“药审办”寄送给有关的审评委员作进一步审评,如系申请一、二类生产的新药,则要召开有关委员会进行审评,如系申请各类临床或三、四、五类生产的新药,则由“药审办”把委员们的审评意见和“药审办”的意见进行综合分析,写出技术审评报告.到目前为止,在 In the process of approval of new drugs, the application form and materials shall first be submitted to the Pharmaceutical Administration of the Ministry of Health after first instance by the health department of the province (city), three copies shall be given to the Drug Evaluation Office of the Ministry of Health (hereinafter referred to as “Drug Trial Office”), According to the category and type of the new drug reported, the number of copies of the required information submitted by the applicant unit should be further sent to the relevant review committee for further examination by the “Drug Trial Office” Review, such as the application of one or two kinds of new drugs, it is necessary to convene the Committee for review, such as the application of various types of clinical or three, four, five kinds of new drugs produced by the “Drug Audit Office” to members Review and comments of the “Drug Review Office” to conduct a comprehensive analysis of the technical review report. So far, at