첨단바이오의약품 신속처리제도 분석

• 영문명: Analysis of Advanced Therapy Medicinal Product Expedited Processing System: Focusing on the United States, the European Union, Japan and South Korea
• 발행기관: 대한약학회
• 저자명: 정혁교 박지혜 김민수 김승우 김형수 김은영
• 간행물 정보: 『약학회지』제67권 제5호(2023년), 302~310쪽, 전체 9쪽
• 주제분류: 의약학 > 기타의약학
• 파일형태: PDF
• 발행일자: 2023.10.30

영문 초록

In order to address unmet medical needs, regulatory agencies in each country have an expedited processing system that rapidly develops and commercializes Advanced Therapy Medicinal Products. This study analyzed the expedited processing systems of the United States, European Union, Japan, and South Korea by referring to the websites of regulatory agencies and related regulations and documents. The expedited processing system is divided into approval pathway and designation, where approval pathway is the mechanism for marketing approval, while designation is given to drugs that meet specific criteria. Among several systems, South Korea has customized examination and conditional approval within expedited processing clauses, the United States has Regenerative Medicine Advanced Therapy, the European Union has PRIME, and Japan has Sakigake. Although there are differences in the conditions for being designated as subject to expedited processing in each country, most of the other conditions stipulate similar contents. In order for the expedited processing system of the Advanced Regenerative Bio Act to achieve international harmony, domestic regulatory agencies must actively intervene to achieve interaction in the development process of Advanced Therapy Medicinal Products, and multidisciplinary and multi-institutional organizations must participate together.

목차

서 론(Introduction)

방 법(Methods)

결 과(Results)

고 찰(Discussion)

결 론(Conclusion)

감사의 말씀(Acknowledgment)

Conflict of Interest

References

키워드

Advanced Therapy Medicinal Products Expedited processing system Expedited approval Expedited program Fast Track