Analysis and Reflection on Common Issues in Registration Inspection during Drug Registration Review Process

OBJECTIVE To summarize the registration testing problems frequently consulted by the applicant in the process of drug registration review, the common problems are analyzed and discussed to provide reference for the applicant, so as to further improve the efficiency of registration review.

METHODS Combined with the current laws and regulations as well as the requirements of drug registration testing, the problems found during the registration testing of registration review process for drug registration were classified and analyzed. The aspects of the situation of starting the registration testing, the requirements for registration inspection during the registration review process, the starting of the original and auxiliary package registration testing, and the problems of the secondary registration testing were described.

RESULTS & CONCLUSION  The applicant should complete the relevant preparations for registration testing according to the requirements of the drug evaluation institution and drug testing institute before applying for registration, and the drug regulatory authority should further improve the registration testing specifications and procedures, with a view to accelerating the review, and enhancing the predictability of the total time limit for review and approval.