공지
- [ 2024-07-15 ] 『생명, 윤리와 정책』제8권 제2호 원고 모집 안내(~9/20)
- [ 2024-07-12 ] 정책원 대표 홈페이지 이용자 만족도 및 사용편의성 조사 연장(20...
- [ 2024-06-28 ] 2024년 하반기(7월) 유전자검사기관 종사자 교육 안내
- [ 2024-06-12 ] 2024년 하반기 DTC 유전자검사기관 검사역량인증 사업 설명회 개...
- [ 2024-06-11 ] 2024 연명의료결정제도 수기·영상 공모전 안내
관련 논문
*정책원 미소장 자료이며 관련 논문 소개 게시판입니다. 게시물 관련링크를 눌러 소속기관에서 열람가능한지 확인해주시기 바랍니다.
lib@nibp.kr
글 수 869
| 발행년 : | 2008 |
|---|---|
| 구분 : | 국내학술지 |
| 학술지명 : | 藥學硏究論文集 |
| 관련링크 : | http://www.riss.kr/link?id=A75064621 |
국내 희귀의약품의 현황 및 과제 : 희귀질환에 대한 의약품 공급을 중심으로
= Current Status and Expectations of Orphan Drugs in Korea : In point of supplying medicines for the rare diseases
- 저자명
김희은, 곽혜선
- 학술지명
藥學硏究論文集
- 권호사항
Vol.- No.17 [2008]
- 발행처
이화여자대학교 약학연구소
- 자료유형
학술저널
- 수록면
115-120(6쪽)
- 언어
Korean
- 발행년도
2008년
- KDC
518
- 초록 (Abstract)
- This study was aimed to investigate the curretit status and expectations of orphan drugs in Korea. The Korea Orphan Drug Center was established to supply many medicines for the patients with rare diseases. Among the medicines supplied by the Center, the number designated as the orphan drugs by the K-FDA is quite few. However, a few of medicines are not under circulation even if the items are designated as the orphan drugs. Neoplasm-related medicines, infectious and parasitic disease-related medicines, endocrine, nutritional and metabolic disease-related medicines are the ones circulated most. There are several unapproved drugs among the medicines supplied by the Center. It's because the director of the Center can import the goods without a process to getting an approval from the KFDA. The Korea Orphan Drug Center has contributed to the selection of the medicines for treating the rare disease. On the contrary, some problems remain in the supply process. The safety and effectiveness of the medicines supplied by the Center are not guaranteed. So far, rare diseases have no apecific legal definition, and therefore are only referred to in terms of the population of patients, which prevent from establishing the lange of medicines.
The introduction of Special Access Program ot Access to Unapproved Therapeutic Goods will be the solution ot these problems, In addition, it is, another solution to keep intimate relations with the Rare and Intractable Disease Center and the Medicine Safety Infonnation Center which will be open soon.
(†04522) 서울 특별시 중구 남대문로 113 DB다동빌딩 5층
TEL : 02-737-8970 (기획운영팀)
Copyright (c)KONIBP All Right Reserved.
Copyright (c)KONIBP All Right Reserved.
2sisstore
