Current Location:CDE Procedure Documents
       This page contains the CDE procedures documents developed and issued in recent two years. These procedures set forth and prescribe the principles, procedures, criteria and requirements for CDE review works. The procedures’ developing is a main task and continual process of CDE. CDE will regulate and standardize its’ works and actions by following the procedures to improve the quality and efficiency of drug registration application review and decision-making.
Title issued date
CDE publishes 2012 China Drug Review Annual Report (English Translation) 6/4/2013
Principles and Procedures for Drug Review and Evaluation 4/13/2011
Procedures for Review Task Management (Interim) 10/9/2011
The Procedures for Discipline Review Meeting (Interim) 12/27/2011
Procedures for the Comprehensive Review Meeting (Interim) 12/27/2011
Procedures for Organizing the Expert Consultation Meeting (Interim) 12/27/2011
Procedures for Review Decision-Making Pathways (Interim) 10/9/2011
Procedures for Office Directors’ Joint Meeting (Interim) 12/27/2011
Quality Management Procedures for the Communication with the Applicants for Drug Registration Application (Interim) 7/11/2012
Procedures for Communication Meeting Between CDE and Drug Registration Applicants (Interim) 12/27/2011
Procedures for Joint-Review Meetings after Pharmaceutical Manufacturing Site Inspection (Interim) 12/27/2011
 
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