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财税[2015]2号国家食品药品监督管理总局,各省、自治区、直辖市财政厅(局)、发展改革委、物价局:按照《国务院机构改革和职能转变方案》的要求,为进一步规范行政事业性收费管理,现将重新审核后中央管理的食品药品监督管理部门行政事业性收费项目及有关问题通知如下:一、药品注册费(一)新药注册费。国家食品药品监督管理总局在受理新药(含参照新药申报的进口药品)注册(包括临床试验注册、生产注册)申请时,向申请人收取。(二)仿制药注册费。国家食品药品监督管理总局在受理仿制药(含参照仿制药申报的进口
Ministry of Finance, Bureau of Development and Reform Commission and Price Bureau of all provinces, autonomous regions and municipalities directly under the Central Government: In accordance with the requirements of the “State Department’s Institutional Reform and Functional Transformation Program”, Cai Shui [2015] No. 2 State Food and Drug Administration, Charge management, now after re-examination of the central administration of food and drug administration administrative charges and related issues as follows: First, the drug registration fee (A) registration fee for new drugs. The State Food and Drug Administration shall charge the applicant when accepting an application for registration of new drugs (including imported drugs that reference new drugs) (including clinical trial registration and production registration). (B) generic drug registration fee. State Food and Drug Administration in the acceptance of generic drugs (including reference to generic import declaration