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임상시험용 의약품의 안전성 정보보고를 위한 평가 등 관리방안 설문조사 연구

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

한국임상약학회지 2021년 31권 1호 p.53 ~ 60
이보미, 박상준, 심다영, 이하은, 이정은, 김상희, 조혜경, 신주영,
소속 상세정보
이보미 ( Lee Bo-Mi ) - Sungkyunkwan University School of Pharmacy
박상준 ( Park Sang-Jun ) - Sungkyunkwan University School of Pharmacy
심다영 ( Shim Da-Young ) - Sungkyunkwan University School of Pharmacy
이하은 ( Rhee Ha-Eun ) - Sungkyunkwan University School of Pharmacy
이정은 ( Lee Jeong-Eun ) - Sungkyunkwan University School of Pharmacy
김상희 ( Kim Sang-Hee ) - Sungkyunkwan University School of Pharmacy
조혜경 ( Cho Hea-Kyoung ) - Sungkyunkwan University School of Pharmacy
신주영 ( Shin Ju-Young ) - Sungkyunkwan University School of Pharmacy

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.

키워드

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

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