regulatory submission信息详情
监督意见书
submission───n.投降;提交(物);服从;(向法官提出的)意见;谦恭
submission confirmation───提交确认
regulatory approval───注册审批;监管批准
submission status───提交状态
manuscript submission───投稿
regulatory affairs───法规事务
submission deadline───提交最终期限;提交截止日期
regulatory risk───监管风险
regulatory sandbox───监管沙箱
For more information on electronic submissions, see electronic Regulatory submission and Review.───关于电子递交方面的更多信息,请参见电子格式递交及评审。
Support Regulatory Affairs as needed for domestic and international submissions from manufacturing perspective required by the US FDA, China CFDA and international submission in designated countries.───支持本地和国际法务工作,需要时支持中国和国际生产注册提交,以符合美国FDA及中国FDA和各国的要求。
Statutory or other regulatory requirements may demand minimum retention periods or submission to an authorizing body such as an archival authority or auditors for any necessary approval.───法规或其他规章需求可能会订定最小保存期限或要求将此事交给一个经授权的机构,例如:具认可之档案主管机构或稽核单位。
Working with relevant function within Company responsible for the submission content to prepare the regulatory submission.───协调公司内部相关注册支持部门的工作,进行注册资料的准备。
P. 2 Pharmaceutical Development section of a regulatory submission in the ICH M4 Common Technical document (CTD) format.───药品开发章节中关于以ICHM4通用技术文件(CTD)格式提交药政申请的建议内容进行描述。
For more information on electronic submissions, see Electronic Regulatory Submission and Review.───关于电子递交方面的更多信息,请参见电子格式递交及评审。
Roche said it expects a global regulatory submission by the middle of 2012.───罗氏制药公司表示,预计将于2012年年中向全球药物监管部门提交申请。
Idea is to harmonize the organization of a regulatory submission───主旨是协调递交形式的管理?
Responsible for clinical part of regulatory submission dossier and answering questions raised by CDE───负责新产品注册资料临床部分的准备并解答CDE提出的问题
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