Korean J Clin Pharm.  2021 Mar;31(1):53-60. 10.24304/kjcp.2021.31.1.53.

A survey for Management of Drug Safety Evaluation System for Investigational Product

• Lee BM
• Park SJ
• Shim DY
• Rhee HE
• Lee JE
• Kim SH
• Cho HK
• Shin JY

• KMID: 2517304
• DOI: http://doi.org/10.24304/kjcp.2021.31.1.53

Abstract

Objective
To gather the opinions of hands-on workers for successful introduction of the Development Safety Update Report (DSUR) according to a five-year comprehensive plan for clinical trial development [Ministry of Food and Drug Safety, 2019].
Methods
We conducted a survey on considerations that industry stakeholders may have related to the enforcement of the DSUR. A questionnaire was distributed among pharmacovigilance specialists from 13 pharmaceutical companies in South Korea on June 4, 2020. The questionnaire comprised two sections: 1) current status of the Drug Safety Data Management System and 2) considerations on the implementation and management of the DSUR.
Results
All respondents have agreed the introduction of DSUR is inevitable for regulatory harmonization and safety of trial subject. However, most respondents (85%) felt concern about additional workload with DSUR implementation. They answered that format and operation system of DSUR should be harmonized with those of international standards and authorities need to minimize double burden due to related report.
Conclusion
All respondents asserted that domestic DSUR should be harmonized with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E2F guidelines. Respondents from global companies also suggested regulatory authorities allow DSUR written in English to replace Korean version considering their deadline for submission. Moreover, every respondent agreed regulatory authorities need delicate effort when implementing mandatory submission of DSUR to ensure that even small pharmaceutical companies with no experience in DSUR can comply with the system.

Keyword

Clinical trials; safety information; investigational product; development safety update report; DSUR