해외 규제기관의 의약품 임상시험 비대면 실태조사 운영 현황 비교 (A Comparison of Current Status of Remote/virtual GCP Inspections by Foreign Regulatory Agencies)

서지정보

· 발행기관 : 한국사회약학회
· 수록지 정보 : 한국사회약학회지 / 9권 / 2호 / 131 ~ 138페이지
· 저자명 : 손세린, 김송희, 곽미송, 이지연, 김상희, 조혜경, 박성민, 장진원, 신주영

초록

GCP Inspection is carried out to improve the quality of clinical trials, and to strengthen the safety and protection of the rights of clinical trial subjects. Recently, On-site GCP inspection has become difficult due to COVID-19 prolongation. This phenomenon has increased the need for remote/virtual GCP Inspections to strengthen the information protection and the clinical trial management. In this paper, current status of global remote/virtual GCP Inspections is investigated through several emergency guidelines, recently issued by foreign regulatory agencies such as the US FDA, European EMA, and Japanese PMDA. Considerations for domestic introduction derived from these guidelines are like: (1) Records assessment of US FDA (2) Feasibility Assessment of the European EMA (3) overall procedure of Japan PMDA guideline. From a legal point of view, the domestic personal information protection law is similar to the GDPR of Europe, and it means that conducting rSDV for medical institutions is difficult. Therefore, obtaining consent for the use of personal information from clinical trial subjects and finding rSDV method considering security are essential to conduct remote/virtual inspections. Remote/virtual GCP Inspections guidelines, which are in harmony with global regulatory trends, can be used as standards for examining high-quality clinical trials, regulatory guidelines for drug development and management, and springboard for document management of RWD.

영어초록

GCP Inspection is carried out to improve the quality of clinical trials, and to strengthen the safety and protection of the rights of clinical trial subjects. Recently, On-site GCP inspection has become difficult due to COVID-19 prolongation. This phenomenon has increased the need for remote/virtual GCP Inspections to strengthen the information protection and the clinical trial management. In this paper, current status of global remote/virtual GCP Inspections is investigated through several emergency guidelines, recently issued by foreign regulatory agencies such as the US FDA, European EMA, and Japanese PMDA. Considerations for domestic introduction derived from these guidelines are like: (1) Records assessment of US FDA (2) Feasibility Assessment of the European EMA (3) overall procedure of Japan PMDA guideline. From a legal point of view, the domestic personal information protection law is similar to the GDPR of Europe, and it means that conducting rSDV for medical institutions is difficult. Therefore, obtaining consent for the use of personal information from clinical trial subjects and finding rSDV method considering security are essential to conduct remote/virtual inspections. Remote/virtual GCP Inspections guidelines, which are in harmony with global regulatory trends, can be used as standards for examining high-quality clinical trials, regulatory guidelines for drug development and management, and springboard for document management of RWD.

참고자료

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