첨단바이오 포커스

국민의 안전과 건강을 지키는 한국의약품안전관리원

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제목 첨단바이오 포커스 제5호
등록자 hyj0117 등록일 2021-05-06 조회수 555

















Reference

1. 식품의약품안전처 홈페이지 Available from: https://www.mfds.go.kr/brd/m_99/view.do?seq=45116&srchFr=&srchTo=&srchWord=&srchTp=&itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=4
2. 식품의약품안전처 홈페이지 Available from: https://www.mfds.go.kr/brd/m_99/view.do?seq=45169&srchFr=&srchTo=&srchWord=&srchTp=0&itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&Data_stts_gubun=C9999&page=2
3. 식품의약품안전처 홈페이지 Available from: https://www.mfds.go.kr/brd/m_99/view.do?seq=45218&srchFr=&srchTo=&srchWord=&srchTp=0&itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&Data_stts_gubun=C1009&page=1
4. 식품의약품안전처 홈페이지 Available from: https://www.mfds.go.kr/brd/m_1059/view.do?seq=14820&srchFr=&srchTo=&srchWord=&srchTp=&itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1
5. 과학기술정보통신부 홈페이지 Available from: https://www.msit.go.kr/bbs/view.do?sCode=user&mId=113&mPid=112&pageIndex=2&bbsSeqNo=94&nttSeqNo=3180026&searchOpt=ALL&searchTxt=
6. 이승덕 기자. 복지부, 22개 상급종병과 ‘첨단재생의료 실시’ 첫 회동, 의학신문(2021.3.3.) Available from: http://www.bosa.co.kr/news/articleView.html?idxno=2145387
7. 질병관리청 홈페이지 Available from: http://www.kdca.go.kr/board/board.es?mid=a20501020000&bid=0015&list_no=712685&cg_code=C01&act=view&nPage=3
8. 과학기술정보통신부 홈페이지 Available from: https://www.msit.go.kr/bbs/view.do?sCode=user&mId=113&mPid=112&pageIndex=1&bbsSeqNo=94&nttSeqNo=3180044&searchOpt=ALL&searchTxt=
9. 보건복지부 홈페이지 Available from: https://www.mohw.go.kr/react/al/sal0301vw.jsp?PAR_MENU_ID=04&MENU_ID=0403&page=1&CONT_SEQ=364179
10. “FDA grants accelerated approval to axicabtagene ciloleucel for relapsed or refractory follicular lymphoma” US FDA. Accessed Mar.8, 2021 Available from: https://www.fda.gov/drugs/drug-approvals-and-databases/fda-grants-accelerated-approval-axicabtagene-ciloleucel-relapsed-or-refractory-follicular-lymphoma
11. “Approval Letter: ZOLGENSMA” US FDA. Accessed Mar.16, 2021 Available from: https://www.fda.gov/media/146736/download
12. “Approval Letter: ABECMA” US FDA. Accessed Mar.27, 2021 Available from: https://www.fda.gov/media/147062/download
13. “FDA NEWS RELEASE: FDA Approves First Cell-Based Gene Therapy for Adult Patients with Multiple Myeloma” US FDA, Accessed Mar.27, 2021 Available from: https://www.fda.gov/news-events/press-announcements/fda-approves-first-cell-based-gene-therapy-adult-patients-multiple-myeloma
14. “TRG Rapid Inquiry Program (TRIP)” US FDA, Accessed Mar.31, 2021 Available from: https://www.fda.gov/vaccines-blood-biologics/trg-rapid-inquiry-program-trip
15. “Center for Biologics Evaluation and Research (CBER) 2021-2025 Strategic Plan” US FDA. Accessed Mar.19, 2021 Available from: https://www.fda.gov/media/81152/download
16. “Public Meeting: FDA Rare Disease Day 2021” US FDA. Accessed Mar.5, 2021 Available from: https://www.fda.gov/news-events/fda-meetings-conferences-and-workshops/public-meeting-fda-rare-disease-day-2021-03052021-03052021
17. “Libmeldy” EMA. Accessed Mar. 9, 2021 Available from: https://www.ema.europa.eu/en/medicines/human/EPAR/libmeldy
18. “COVID-19-vaccine-janssen” EMA. Accessed Mar. 11, 2021 Available from: https://www.ema.europa.eu/en/medicines/human/EPAR/covid-19-vaccine-janssen
19. “ Committee for Advanced Therapies (CAT): work-plan-2021” EMA. Accessed Mar. 10, 2021 Available from: https://www.ema.europa.eu/en/documents/other/cat-work-plan-2021_en.pdf
20. “CHMP monthly report of application procedures, guidelines and related documents on advanced therapies” EMA. Accessed Mar. 3, 2021 Available from: https://www.ema.europa.eu/en/documents/agenda/agenda-chmp-agenda-22-25-march-2021-meeting_en.pdf
21. “recommendations eligibility prime scheme adopted CHMP meeting 22-25 march 2021” EMA. Accessed Mar. 2021 Available from: https://www.ema.europa.eu/en/documents/chmp-annex/recommendations-eligibility-prime-scheme-adopted-chmp-meeting-22-25-march-2021_en.pdf
22. “Orphan designations-eu3171958” EMA. Accessed Mar. 22, 2021 Available from: https://www.ema.europa.eu/en/medicines/human/orphan-designations/eu3171958
23. 최선례 기자. 日 JCR파마, ‘템셀’ 표피수포증 적응확대 개발 중지, 약업신문(2021.3.9.) Available from: http://www.yakup.com/news/index.html?mode=view&cat=16&nid=255005
24. Courtney Marabella. Liso-Cel Approved in Japan for Relapsed/Refractory Large B-Cell Lymphoma, OncLive(21.3.30.) Available from: https://www.onclive.com/view/liso-cel-approved-in-japan-for-relapsed-refractory-large-b-cell-lymphoma
25. 식품의약품안전처 홈페이지 Available from: https://www.mfds.go.kr/brd/m_99/view.do?seq=45116
26. 식품의약품안전처 식품의약품안전평가원: 첨단바이오의약품의 장기추적  조사 가이드라인, 2020.12 Available from: http://www.nifds.go.kr/brd/m_15/view.do?seq=12941
27. “Guidance for Industry: Long Term Follow-Up After Administration of Human Gene Therapy Products” US FDA. Accessed 2020 Available from: https://www.fda.gov/media/113768/download
28. “Guidance Document: Guideline on safety and efficacy follow-up and risk management of Advanced Therapy Meducunal Products” EMA, Accessed 2018
29. 식품의약품안전처 바이오생약국: 첨단바이오의약품 환자안전관리 종합계획 장기추적조사 의무화, 2020
30. “Guidance Document: Guideline on Follow-up of patients administered with gene therapy medical products” EMA, Accessed 2010
31. 식품의약품안전처: 유전자치료제 임상시험 가이드라인 – 지연성 이상반응에 대비한 환자 추적관찰, 2016 http://www.nifds.go.kr/brd/m_15/view.do?seq=12644&srchFr=&srchTo=&srchWord=&srchTp=&itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=59
32. “Guidance Document: Guideline on good pharmacovigilance practices (GVP) Module VII – Periodic safety update report (Rev 1)” EMA. Accessed 2013
33. 식품의약품안전처: 줄기세포치료제 장기추적조사 가이드라인, 2016 Available from: https://www.nifds.go.kr/brd/m_158/view.do?seq=11720
34. 식품의약품안전평가원: 유럽 최신 약물감시 규정 자료집, 2018 Available from: https://www.nifds.go.kr/brd/m_18/view.do?seq=12176&srchFr=&srchTo=&srchWord=%EC%9C%A0%EB%9F%BD+%EC%B5%9C%EC%8B%A0+%EC%95%BD%EB%AC%BC%EA%B0%90%EC%8B%9C+%EA%B7%9C%EC%A0%95+%EC%9E%90%EB%A3%8C%EC%A7%91&srchTp=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1
35. “Guidance Document: Guideline on Follow-up of patients administered with gene therapy medical products” EMA, Accessed 2009 Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-follow-patients-administered-gene-therapy-medicinal-products_en.pdf

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