CNDA released the Announcement on Adjusting Evaluation and Approval Procedures for Clinical Trials for Drugs (“Announcement”) on 24 July 2018.
According to the Announcement, it is advisable for an applicant of a new drug to join a communication meeting with CDE of the CNDA before filing the application of the first-time clinical trial. The purpose of the communication meeting is to make sure that the applicant understands the standards and requirements of the clinical trial application. In the communication meeting, CDE will discuss the key technical questions and the safety of the study subjects of the clinical trial with the applicant. After the communication meeting, CDE might ask the applicant to supplement the materials and data with further documentation, following which the applicant can then file the clinical trial application. CDE will finish the format review within 5 days and then issue a Notice of Acceptance (“Notice”). If the applicant does not receive any negative or challenging opinions from CDE within 60 days of the Notice, it means that the application has been approved and the applicant can start the clinical trial.
In each stage of the clinical trial, the applicant can apply for communication meetings to CDE if the applicant is not sure about any key technical issues.
Please click here to read the full text of the Announcement (in Chinese only).