Reference
1. 식품의약품안전처 홈페이지Available from: https://www.mfds.go.kr/brd/m_99/view.do?seq=45644&srchFr=&srchTo=&srchWord=&srchTp=&itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=3
2. 식품의약품안전처 홈페이지Available from: https://www.mfds.go.kr/brd/m_203/view.do?seq=3155
3. 식품의약품안전처 홈페이지Available from: https://www.mfds.go.kr/brd/m_99/view.do?seq=45602&srchFr=&srchTo=&srchWord=&srchTp=&itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=3
4. 식품의약품안전처 홈페이지Available from: https://www.mfds.go.kr/brd/m_1059/view.do?seq=14859&srchFr=&srchTo=&srchWord=&srchTp=&itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1
5. 보건복지부 홈페이지Available from: http://www.mohw.go.kr/react/al/sal0301vw.jsp?PAR_MENU_ID=04&MENU_ID=0403&page=3&CONT_SEQ=366707
6. “Cumulative CBER Regenerative Medicine Advanced Therapy (RMAT) Designation Requests Received by Fiscal Year” US FDA Accessed July 6, 2021 Available from: https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/cumulative-cber-regenerative-medicine-advanced-therapy-rmat-designation-requests-received-fiscal
7. “Questions and Answers Regarding the End of the Compliance and Enforcement Policy for Certain Human Cells, Tissues, or Cellular or Tissue-based Products (HCT/Ps)” US FDA
Accessed July 9, 2021Available from: https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/questions-and-answers-regarding-end-compliance-and-enforcement-policy-certain-human-cells-tissues-or
8. “CBER targets four stem cell firms with untitled letters” Regulatory Focus
Accessed July 20, 2021 Available from: https://www.raps.org/news-and-articles/news-articles/2021/7/cber-pummels-four-firms-for-marketing-unapproved-s
9. “Regulatory Education for Industry (REdI) Annual Conference 2021” US FDA Accessed July 23, 2021
Available from: https://www.fda.gov/drugs/regulatory-education-industry-redi-annual-conference-2021-07192021-07232021
10. “Cellular, Tissue, and Gene Therapies Advisory Committee September 2-3, 2021 Meeting Announcement” US FDA Accessed July 27, 2021
Available from: https://www.fda.gov/advisory-committees/advisory-committee-calendar/cellular-tissue-and-gene-therapies-advisory-committee-september-2-3-2021-meeting-announcement
11. “Committee for Advanced Therapies (CAT): work-plan-Jul” EMA. Accessed Jul. 15, 2021 Available from: https://www.ema.europa.eu/en/events/committee-advanced-therapies-cat-14-16-july-2021
12. EMA 홈페이지 Available from: https://www.ema.europa.eu/en/medicines/human/referrals/zynteglo
13. “Orphan designations-eu3181999” EMA. Accessed Jul. 1. 2021
Available from: https://www.ema.europa.eu/en/medicines/human/orphan-designations/eu3181999
https://www.ema.europa.eu/en/medicines/human/referrals/zynteglo
14. “Orphan designations-eu3171950” EMA. Accessed Jul. 12. 2021
Available from: https://www.ema.europa.eu/en/medicines/human/orphan-designations/eu3171950
15. “Orphan designations-eu3202351” EMA. Accessed Jul. 12. 2021
Available from: https://www.ema.europa.eu/en/medicines/human/orphan-designations/eu3202351
16. “Orphan designations-eu3151577” EMA. Accessed Jul. 12. 2021
Available from: https://www.ema.europa.eu/en/medicines/human/orphan-designations/eu3151577
17. “Orphan designations-eu3121002” EMA. Accessed Jul. 16. 2021
Available from: https://www.ema.europa.eu/en/medicines/human/orphan-designations/eu3121002
18. “Orphan designations-eu3192138” EMA. Accessed Jul. 21. 2021
Available from: https://www.ema.europa.eu/en/medicines/human/orphan-designations/eu3192138
19. “Orphan designations-eu3121003” EMA. Accessed Jul. 27. 2021
Available from: https://www.ema.europa.eu/en/medicines/human/orphan-designations/eu3121003
20. “Yescarta” EMA. Accessed Jul. 8, 2021
Available from: https://www.ema.europa.eu/en/medicines/human/EPAR/yescarta
21. “Sperox” EMA. Accessed Jul. 14, 2021
Available from: https://www.ema.europa.eu/en/medicines/human/EPAR/spherox
22. PMDA 홈페이지Available from: https://www.pmda.go.jp/english/symposia/0211.html
23. “JMuscles retain positional memory from fetal life” Eurekalert. Accessed July. 6, 2021
Available from: https://www.eurekalert.org/news-releases/575847
24. 유럽의약품청 의약품허가제도, 식품의약품안전평가원 APEC규제조화센터,2020.12
25. “advanced-therapy-medicinal-products-overview” EU EMA 홈페이지
Available from: https://www.ema.europa.eu/en/human-regulatory/overview/advanced-therapy-medicinal-products-overview
26. “committee-advanced-therapies-cat-overview” EU EMA 홈페이지
Available from: https://www.ema.europa.eu/en/committees/committee-advanced-therapies-cat
27. “European Medicines Agency pre-authorisation procedural advice for
users of the centralised procedure. EMA/821278/2015”, EU EMA, Accessed 2019
28. “Scientific Recommendation on classification of Advanced Therapy Medicinal
Products Request Form and Briefing Information Article 17 - Regulation (EC)
No 1394/2007”, EU EMA, Accessed 2019
29. “Legal framework: Advanced Therapies” EU EMA 홈페이지 Available from:
https://www.ema.europa.eu/en/human-regulatory/overview/advanced-therapies/legal-framework-advanced-therapies
30. “regulatory procedural guideline CAT rules procedure”, EU EMA, Accessed
March 19, 2020 Available from: https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/cat-rules-procedure_en.pdf
31. “CAT members: The European Medicines Agency publishes details of the
members and alternates of its Committee for Advanced Therapies” EU EMA 홈
페이지 Available from: https://www.ema.europa.eu/en/committees/cat/members
32. “CAT agenda june 2021 meeting”, EU EMA, Accessed June 16, 2021
Available from: https://www.ema.europa.eu/en/committees/cat/cat-agendas-minutes-reports
33. 첨단바이오의약품 원료세포 품질 안전기준 마련 및 교육, 한국의약품안전관리원, 2020.11
34. “committee advanced therapies european society gene cell therapy satellite
workshop advanced therapy” ,EU EMA, Accessed Oct 27, 2011
Available from: https://www.ema.europa.eu/en/events/committee-advanced-therapies-european-society-gene-cell-therapy-satellite-workshop-advanced-therapy
35. “cat translational centre regenerative medicine leipzig collaborative
workshop advanced therapy” ,EU EMA, Accessed Oct 23, 2013
Available from: https://www.ema.europa.eu/en/events/cat-translational-centre-regenerative-medicine-leipzig-collaborative-workshop-advanced-therapy
36. “committee advanced therapies cat german society transfusion medicine
immunohaematology dgti workshop”, EU EMA, Accessed Sep 11, 2014
Available from: https://www.ema.europa.eu/en/events/committee-advanced-therapies-cat-german-society-transfusion-medicine-immunohaematology-dgti-workshop
37. “committee advanced therapies cat international society cellular therapy
isct workshop challenges”, EU EMA, Accessed Sep 25, 2015
Available from: https://www.ema.europa.eu/en/events/committee-advanced-therapies-cat-international-society-cellular-therapy-isct-workshop-challenges
38. “committee advanced therapies cat workshop scientific regulatory challenges genetically modified cell”, EU EMA, Accessed Nor 11, 2016
Available from: https://www.ema.europa.eu/en/events/committee-advanced-therapies-cat-workshop-scientific-regulatory-challenges-genetically-modified-cell