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日前,北京市药品监督管理局转发了国家药监局《关于新药审批工作有关事项的通知》,并要求北京市各有关药品申请单位认真遵照执行。通知指出,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决定如下: 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。
Recently, the Beijing Municipal Administration of Drug Administration forwarded the State Food and Drug Administration “on the approval of new drugs related matters notice” and requested that all relevant Beijing drug application units to comply with the implementation. The circular pointed out that since the second half of 2001, the number of new drug applications has risen sharply. In order to ensure the quality of drug reviews and strengthen drug registration management, the following are the issues concerning the examination and approval of new drugs: 1. New drugs accepted from December 1, 2001 up to the date of implementation of the “Drug Registration Regulations” The approval deadline shall be postponed for 100 days.