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各省、自治区、直辖市药品监督管理局,解放军总后卫生部: 自2001年下半年以来,新药的申报数量急剧增加,为保证药品审评质量,加强药品注册管理,现就新药审批工作的有关问题通知如下: 一、对2001年12月1日起至新的《药品注册管理办法》实施之日前受理的新药,其审批时限一律顺延100天。 二、关于对药品审评过程中补充资料的要求; (一)本通知发布之日前我局新药审评中心已
Since the second half of 2001, the number of new drug applications has dramatically increased. To ensure the quality of drug reviews and to strengthen drug registration and management, the relevant issues concerning the examination and approval of new drugs are hereby announced The notice is as follows: 1. The approval period for new drugs accepted from December 1, 2001 up to the date of implementation of the new Drug Registration Management Measures shall be extended by 100 days. Second, on the drug review process of additional information requirements; (A) the date of this notice issued by the new drug review center has