Pharmaceutical
ChemLinkedMarketChemicalFoodCosmeticPharmaceuticalJapanAgrochemicalSustainability
Guidance for the Acceptance Review of Chemical Drug Registration Applications (Trial)
Request Guidance for the Acceptance Review of Chemical Drug Registration Applications (Trial)
  • Local Title:化学药品注册受理审查指南（试行）
  • Country/Region:Chinese Mainland
  • Competent Authority: Center for Drug Evaluation (CDE)
  • Type:Guideline
  • Status:In force
  • Release Date:2020-07-03
  • Implementation Date:2020-07-03
Request
Document
Language Source Title Access
ZH Official 化学药品注册受理审查指南（第一部分 注册分类1、2、5.1类）（试行） Download
ZH Official 化学药品注册受理审查指南（第二部分 注册分类3、4、5.2类）（试行） Download
Summary

The Guidance applies to the acceptance review of clinical trial applications / marketing authorization applications for chemical drugs. CDE requires the application dossiers be prepared according to current version of ICH Guideline M4: The Common Technical Document (CTD).

Most Popular