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Original Article

미국, 유럽, 한국의 혁신적 첨단재생바이오의약품 관련 제도 비교 연구

원문정보

Studies on the Comparison of the Expedited Programs for Regenerative Medicine Therapies among the United States, the European Union and the Republic of Korea

고채은, 이장익

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초록

영어

Background: The authors performed gap analyses on the expedited programs associated with regenerative medicine therapies (RMTs), offered by Food and Drug Administration (FDA), European Medicines Agency (EMA) and Ministry of Food and Drug Safety (MFDS). Methods: The regulations and guidelines on expedited programs (e.g., Regenerative Medicine Advanced Therapy [RMAT] designation) associated with RMTs, and regulatory reviews on approved RMTs were retrieved from the websites of FDA, EMA and MFDS. Based on analyses of the retrieved materials, gap analyses were performed on the qualifying criteria, features and operational frameworks. Included were the comparisons of the expedited programs granted for tisagenlecleucel among the agencies. Results: FDA offers RMAT, Fast Track, Breakthrough Therapy, Priority Review designations, and Accelerated Approval. EMA’s programs include PRIority MEdicines (PRIME), Accelerated Assessment, Exceptional Circumstances, and Conditional Marketing Authorisation. MFDS implements a single Fast-Track Processing program. RMAT designation is specific to RMTs and can be utilized with FDA’s other expedited programs. PRIME applies to all medicinal products and can be used with EMA’s other programs. Fast-Track Processing program is specific to RMTs but combines all expedited features into a single track. Tisagenlecleucel received RMAT, Priority Review and Accelerated Approval for follicular lymphoma from FDA, PRIME for acute lymphocytic leukemia from EMA, and Fast-Track Processing for follicular lymphoma from MFDS. Conclusion: FDA offers the RMAT designation exclusive to expediting the development, review and approval of RMTs in addition to other expedited programs, whereas EMA does RMT approvals under expedited drug approval programs. MFDS implements an exclusive, single-track program for RMTs.

목차

ABSTRACT
연구 방법
연구 결과
FDA의 혁신적 첨단재생바이오의약품 관련 제도
EMA의 혁신적 첨단재생바이오의약품 관련 제도
식약처의 혁신적 첨단재생바이오의약품 관련 제도
갭분석 수행
규제기관별 혁신적 첨단재생바이오의약품 관련 제도에 따른 tisagenlecleucel의 허가
고찰
결론
감사의 글
이해 상충
References

저자정보

  • 고채은 ChaeEun Ko. 서울대학교 약학대학
  • 이장익 Jangik I. Lee. 서울대학교 약학대학, 서울대학교 약학대학 종합약학연구소

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