These rules are built in accordance the information provided in the following documents: Guidance Document - Preparation of Drug Regulatory Activities in Electronic Common Technical Document (eCTD) ...
All year-end and CSV data is "as traded on the day" and ignores corporate actions (e.g. share splits) ...
Managing the procurement and delivery of travel and accommodation agency services for its clients.
中eCTD实施范围基础上,进一步扩大实施范围,自2025年1月27日起,化学药品1类至5类的药物临床试验申请,化学药品2类、3类、4类、5.2类的上市许可申请,以及预防用生物制品和治疗用生物制品1类至3类的药物临床试验申请、2类和3类的上市许可申请,可按照eCTD ...
Background and objective Gastric cancer (GC) remains a prevalent and preventable disease, yet accurate early diagnostic methods are lacking. Exosome non-coding RNAs (ncRNAs), a type of liquid biopsy, ...
1月23日,国家药监局网站发布《关于扩大药品电子通用技术文档实施范围的公告》,全文如下。 国家药监局关于扩大药品电子通用技术文档实施范围的公告 (2025年第10号) 为加快推进药品电子通用技术文档(以下简称eCTD)在我国的实施进程,提升“互联网 ...
it should be placed in Module 4.2.3.4 of the Common Technical Document (CTD) structure. It is also recommended that their inclusion is mentioned in the submission cover letter with a strong rationale ...