한국임상약학회지 (Korean Journal of Clinical Pharmacy)

  • 제31권1호
  • /
  • Pages.53-60
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  • 2021
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  • 1226-6051(pISSN)
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  • 2508-786X(eISSN)
한국임상약학회 (Korean College Of Clinical Pharmacy)
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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

  • 이보미 (성균관대학교 약학대학) ;
  • 박상준 (성균관대학교 약학대학) ;
  • 심다영 (성균관대학교 약학대학) ;
  • 이하은 (성균관대학교 약학대학) ;
  • 이정은 (성균관대학교 약학대학) ;
  • 김상희 (성균관대학교 약학대학) ;
  • 조혜경 (성균관대학교 약학대학) ;
  • 신주영 (성균관대학교 약학대학)
  • 투고 : 2020.12.23
  • 심사 : 2021.02.25
  • 발행 : 2021.03.31
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초록

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

참고문헌

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