一)综述资料(Summary Information)

药品说明书翻译 Translation of drug instructions

药品翻译 Medicine Chinese Translation

1、药品名称 name of drug

2. 证明性文件 Certificate files

出口国药品主管当局允许上市销售的证明文件 Certificate of permission for marketing by the country or region drug authority

药品GMP证明文件(原件，如果是复印件，则需要提供公证文件) Certificate of GMP for Pharmaceutical Products (The Originals; The duplicates need notarial certification

3. 上市国上市销售的药品包装标签实样，最好提供 The real labels of drug for marketing

二)药学研究资料(Pharmaceutical Research files)

4. 药学研究资料综述 Summary of Pharmaceutical Research Material

5. 制剂生产工艺的研究资料及文献资料 Research materials and reference materials of drug preparation techniques;

6、质量研究工作的试验资料及文献资料 Test materials and reference materials of quality research

7、药品标准及起草说明 Specification of drug and its explanation

8、样品的检验报告书 The Inspection Report of the Samples

9、原料药、辅料的来源及质量标准、检验报告书 The source, specification and inspection report of the raw materials and excipients

10、药物稳定性研究的试验资料及文献资料 Test materials and reference materials of stability research

11、直接接触药品的包装材料和容器的选择依据及质量标准 The selection basis and specification of primary packaging materials

三)药理毒理研究资料(Pharmacological and toxicological research materials)

12、药理毒理研究资料综述 Summary of pharmacological and toxicological research materials

13、主要药效学试验资料及文献资料 Test materials and reference materials of main pharmacodynamics

14、一般药理学的试验资料及文献资料 Test materials and reference materials of safety pharmacology studies for human pharmaceuticals

15、急性毒性试验资料及文献资料 Test materials and reference materials of acute toxicity

16、长期毒性试验资料及文献资料 Test materials and reference materials of chronic toxicity

17、致突变试验资料及文献资料 Test materials and reference materials of mutagenicity

18、生殖毒性试验资料及文献资料 Test materials and reference materials of germinal toxicity

19、致癌试验资料及文献资料 Test materials and reference materials of carcinogenic

20、非临床药代动力学试验资料及文献资料 Test materials and reference materials of animal dynamics

四)临床试验资料(Clinical research materials)

21、国内外相关的临床试验资料综述 Summary of domestic and foreign clinical study material


本文关键字：药品翻译  药品英文翻译  深圳药品翻译  深圳药品翻译公司  药品翻译公司  药品说明书翻译