줄기세포치료제의 규제에 관한 비교법적 연구
= Comparative Legal Studies on the Regulation of Stem Cell Therapy Products
- 저자[authors] 김현수
- 발행사항 청주 : 충북대학교 일반대학원, 2016
- 형태사항[Description] iv, 64 p. : 삽화 ; 26 cm.
- 일반주기명[Note] 충북대학교 논문은 저작권에 의해 보호됩니다<br>지도교수: 이재목<br>참고문헌: p.63-64
- 학위논문사항[Dissertation] 학위논문(석사)-- 충북대학교 일반대학원 : 법학과 비교법전공 2016. 2
- KDC[Korean Decimal Classification] 360.199 5
- 발행국(발행지)[Country] 충청북도
- 출판년[Publication Year] 2016
- 주제어 줄기세포,stem cell therapies,reasonable,regulatory frameworks
- 소장기관[Holding] 충북대학교 도서관 (243009)
초록[abstracts]
Current law on the stem cell therapy is regulated by the central stem cell therapy are treated with drugs. In principle, it can be used after receiving the pharmaceutical products allowed, it can be used without a license only if a very unusual. This causes several problems to occur in the patient care level.
The first item is authorized, except in circumstances which do not have a system to control against the dangers of stem cell therapies that are able to ensure safety, and The other is the access point, which is too limited to treatment of the patient
It also causes problems that hinder the development of stem cell therapy over safety and related technology due to the strict application of the Marketing Authorisation schemes that require a pre-validated for effectiveness
And the need to solve these problems, this study points out the current regulation of stem cell therapeutics, reasonably suggests improvements to be governed