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**식약처 답변
'연구자주도 임상시험계획의 식약처 승인대상 여부'를 검토한 결과, 시판 중인 의약품 (000 캡슐)의 허가사항 내의 적응증(수지 000 염)을 대상으로 하는 임상시험 이므로 「약사법」 제34조 및 「의약품 등의 안전에 관한 규칙」(총리령) 제24조제3항에 따라 식품의약품안전처장의 승인대상에서 제외됩니다.
○ 동 임상시험은 위약을 대조약으로 사용하는 임상시험이므로, 임상시험의 질환군 및 질환의 중증도, 약물의 투여기간, 피험자 중지 · 탈락기준, 필요시 구제약물 사용 등을 충분히 고려하여 위약군에 포함되는 피험자의 안전성을 확보하여야 할 것이며, 식약처 승인대상에서 제외되므로 임상시험실시기관 IRB에서 위약 사용의 타당성(윤리성 등)에 대한 충분한 심의를 거쳐야 할 것입니다.
**아래 식약처 자주묻는 질문집 검색기 한번 사용해보세요. 🙂
https://clinicaltrialtools.com/식약처-자주하는-질문집-검색/
만약 식약처 승인 필요한 연구라면 식약처에 변경된 계획서 승인 이후 IRB에 변경보고 진행해야하나요? 식약처에 변경된 계획서 승인 이전 IRB측에 변경보고하는 것도 가능한가요???
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