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各省、自治区、直辖市兽医(畜牧、农牧、农业)厅(局、办): 为做好兽药地方标准(以下简称地标)升国家标准(以下简称国标)的工作,根据《兽药管理条例》和农业部第426号公告, 现就有关事项通知如下: 一、2005年7月1日至12月底取得兽药GMP证书的企业,可以申报地标升国标,逾期不受理。二、属于《新兽药及兽药新制剂管理办法》(以下简称4号令)第四、五类新兽药的地标,应按426号公告要求提供材料, 其中临床药效试验方案需符合4号令及《实验临床试验技术规范(试行)》等有关技术规范要求,不得将临床使用证明代替临床药效试验资料。
Veterinary (Bureau of Animal Husbandry, Agriculture and Animal Husbandry) (autonomous regions and municipalities) in all provinces, autonomous regions and municipalities directly under the Central Government: (Bureaus and offices): For the purpose of doing well the national standards of veterinary drugs (hereinafter referred to as the landmarks) Announcement No.426 of the Ministry of Agriculture, the relevant matters are hereby notified as follows: 1. An enterprise that obtained the GMP certificate of veterinary medicine from July 1, 2005 to the end of December 2005 may declare the landmark to be up to the national standard, failing to do so within the prescribed time limit. 2. The landmarks belonging to categories IV and V of new veterinary drugs under the Measures for the Administration of New Drugs and Veterinary Drug New Formulations (hereinafter referred to as Order No.4) shall be provided with the materials as required by Circular No.460, in which the clinical efficacy test program shall comply with Order No. 4 and the “ Experimental Clinical Trial Technical Specification (Trial) ”and other relevant technical specifications, clinical trial should not be used instead of clinical trial data.