Provisions for Communication About Drug R&D and Technical Review
Request Provisions for Communication About Drug R&D and Technical Review
  • Local Title:药物研发与技术审评沟通交流管理办法
  • Country/Region:Chinese Mainland
  • Competent Authority: Center for Drug Evaluation (CDE)
  • Type:Guideline
  • Status:In force
  • Release Date:2020-12-11
  • Implementation Date:2020-12-11
Document
Language Source Title Access
ZH Official 药物研发与技术审评沟通交流管理办法 Download
ZH Official 药物研发与技术审评沟通交流管理办法修订说明 Download
Summary

In the Provisions for Communication About Drug R&D and Technical Review, "communication" means that in the process of drug R&D and the technical review of drug registration application, the applicant communicates with CDE reviewers about the pivotal technology and other issues that cannot be covered by drug R&D and evaluation guidance. 

The meeting should be proposed by the application, deliberated by the CDE executive and the reviewer chosen by the applicant, and held after the approval of the CDE reviewer team.