Analysis of consultation on general technical issues in drug registration application in the Guangdong-Hong Kong-Macao Greater Bay Area
LI Lan-lan
TAN Meng-si
HUANG Xiao-long
Abstract：Objective:To analyze the general technical issues received by the Guangdong-Hong Kong-Macao Greater Bay Area Center for Drug Evaluation and Inspection of National Medical Products Administration when carrying out communication and guidance of drug review in the Greater Bay Area and make suggestions to help drug registration applicants optimize communication.Methods:The general technical issues submitted by applicants from May 2021 to February 2023 were collected from the system,and common consultation questions were summarized and analyzed.Results:A total of 625 general technical questions were received,which were preliminarily classified according to the type of drug registration,including traditional Chinese medicine,chemical drug,biological product,and API.The types of consultation issues were analyzed and summarized,such as technology research and development,clinical trial application,marketing application,supplementary application,etc.,and suggestions were put forward.Conclusion:It is suggested that the applicant fully study the current policies,regulations and technical guidelines,make good use of the consultation channels for general technical issues,raise the corresponding questions reasonably and effectively,solve the practical difficulties in registration and application of research and development,and improve the efficiency of research and development.
Keywords：general technical issuesGuangdong-Hong Kong-Macao Greater Bay Areaguiding principles
Publication Date：2024-04-30
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：7( 761-767 )