Status and analysis of drug registration application in the Guangdong-Hong Kong-Macao Greater Bay Area in 2018-2022
LI Lan-lan
TAN Meng-si
CHENG Bin
HUANG Xiao-long
Abstract：Objective:To analyze the drug registration application in the Guangdong-Hong Kong-Macao Greater Bay Area in the past five years thus to understand the current status and provide reference for promoting the innovative development and transformation of pharmaceutical achievements in this area.Methods:Based on the number of drug registration applications and data from the end of evaluation in the Greater Bay Area over the past five years,as well as some publicly available drugs that have been accelerated to market registration procedures,data processing and statistical analysis were conducted on registration categories,number of innovative drug applications,drug types,and key treatment areas.Results:From 2018 to 2022,a total of 3 496 drug registration applications were submitted in the Great Bay Area,and 3 023 registration applications were completed.The types of registration applications were mainly supplementary applications,with antineoplastic drugs being the most popular track,and the number of approved INDs in the fields of rare diseases,genetic diseases,aging-related diseases,and metabolic diseases has increased significantly.At the same time,the article analyzed the registration applications and approvals of innovative drugs in the Great Bay Area,among which the varieties of innovative biological drugs approved for marketing accounted for 40％of the total number of approvals.Conclusion:In the past five years,with the support of multiple favorable policies,the number of drug registrations and approvals in the Great Bay Area has increased significantly.By combing the overall situation of registration applications in the Great Bay Area and the registration applications in various cities,we learned about the application trends and characteristics of the Greater Bay Area.At the same time,in order to vigorously support the research and development of key varieties in the region,the varieties included in the accelerated marketing and registration procedures of drugs in the region have been sorted out.With the rutine operation of the Greater Bay Area Pharmaceutical Center,it will further promote the high-quality,integrated and international development of the biomedical industry in the Guangdong-Hong Kong-Macao Greater Bay Area.
Keywords：Guangdong-Hong Kong-Macao Greater Bay Areanew druginvestigational new drugnew drug applicationregistration application
Publication Date：2024-06-30
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：9( 1210-1218 )