原文由 ruojun 发表:
To ensure successful implementation of on-site inspection and samplings for drug registration, applicants and relevant research institutions shall make relevant preparations.
原文由 ruojun 发表:
Ruojun: Within 2 working days of receipt of the on-site inspection notification, the applicant shall submit a set of application dossier (including the application form and one hard copy of the acceptance letter) and the on-site inspection notification to the Acceptance Office of the Business Department of SIFDC (located in 1500 Zhangheng Road, Zhangjiang Hi-tech Park). The mobile phone number of the contact person should be provided simultaneously.
原文由 ruojun 发表:
ruojun: Drug Registration (Trial) tentative??
The first two can be downloaded =These documents can be downloaded....
原文由 ruojun 发表:
4、药品研制所涉及的原始记录(包括原辅料检验、处方工艺研究、质量研究、稳定性研究、申报样品试制和检验、药理毒理研究等方面)应按《药品研究实验记录暂行规定》(国药管安[2000]1号)要求归档,参照附表7项目要求,须装订成册(可以线装、胶装、订书钉装等固定,不得采用活页装订或活页夹形式),列出内目录,并有连续页码编号。各试验项目尽可能合并装订。如有委托研究项目,亦应按上述要求提供原始记录,请事先与相关研究单位联系,做好协调工作。
4. File the original records- records of tests of APIs and excipients, formula and process research, quality research, stability study, pilot production and tests of the samples, pharmacology and toxicology study and so on- as required by Temporary Regulations on Experimental Records of Drug Research (Decree No. [2006] 1 issued by the Drug Safety and Supervision Division of SFDA). Bind the records as required by Form 7. The records may be bound with thread, glue or staples, but not in the form of loose leaves. List the contents and number the pages. Try best to bind the records of an item together. Provide original records likewise for commissioned research and contact with relative research organizations beforehand to arrange things.
ruojun: Original records related to drug development (eg.,tests of APIs and excipients, formula and process research, quality research, stability study, pilot production and tests of the samples, pharmacology and toxicology studies, etc.) should be filed by the requirement of Temporary Regulations on Experimental Records of Drug Research (Decree No. [2006] 1 issued by the Drug Safety and Supervision Division of SFDA, see appendix 7). These records might be bound with thread, glue or staples, but not in the form of loose leaves. Contents should be listed and pages should be numbered. Try best to bind the records of an item together. For contracted or commissioned research, original records should be provided likewise. Good communications with these research institutiions should be made beforehand to make sure these requirement can be met.