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《新药审批办法》规定省级药品检验所负责对辖区内申报新药的质量标准(草案)进行技术复核修订,并对新药样品进行检验。现就北京市药品检验所2000年进行新药技术复核检验影响因素讨论分析如下。 1 2000年受理及完成情况 2000年北京市药品检验所受理新药技术复核检验182个品种,完成(2000年受理的新药)148个,未完成34个,详见表1。
The Measures for the Examination and Approval of New Drugs stipulate that the provincial drug inspection institute shall be responsible for revising the technical review of the quality standard (draft) for declaring new drugs within its jurisdiction and examining new drug samples. Now Beijing Institute of Drug Control in 2000 to review the impact of new drug technology to discuss the following factors discussed. 1 Accepted and Completed in 2000 In 2000, Beijing Institute of Drug Control accepted 182 technical tests of new drugs, 148 of which were completed (new drugs accepted in 2000) and 34 were not completed (Table 1).