Earticle

초록

영어

The study was aimed to recommend the ways for improving regulatory system of quasi-drugs in governmental authority by comparing with other countries. According to the regulations, the scope of quasi-drugs includes 3 categories of 1) the health aids made of textile, rubber and paper, 2) the health aids which have very minimal effects or no any effects on humans, and 3) disinfectants and pesticides. In US, these quasi-drugs in Korea are classified into 5 categories of medical device, cosmetics, OTC drugs, dietary supplements and pesticides. To improve quasi-drugs administration in Korea, it is concluded that several measures should be implemented : 1) establish clear criteria for classifying into quasi-drugs and more detailed guidelines on designation of quasi-drugs, 2) reform current regulations to meet 3-categories characteristics, supplement detailed guidelines on quasi-drugs administration for effective application process, and update relevant regulations for efficacy, safety and quality, 3) update quasi-drug monographs, 4) re-evaluate current classification of individual quasi-drugs, 5) develop comprehensive list by ingredients, 6) reform post-marketing management system for safety and quality, 7) strengthen the review agency function by increasing the number of experts, 8) develop the database for quasi-drugs for effective information management.

목차

영문요약
 연구방법
 연구결과
  1. 국내 의약외품 허가심사제도
  2. 미국의 의약외품 허가심사제도
  3. 우리나라와 외국의 비교
  4. 국내 의약외품 허가관리상의 문제점 및 개선방안
 고찰 및 결론
 감사의 말씀
 참고문헌

키워드

저자

• 손현순 [ Hyun Soon Sohn | 숙명여자대학교 약학대학 ]
• 신현택 [ Hyun Taek Shin | 숙명여자대학교 약학대학 ]
• 송인숙 [ In Sook Song | 숙명여자대학교 의약정보연구소 ]
• 전효정 [ Hyo Jung Jun | 숙명여자대학교 약학대학 ]

참고문헌

발행기관

간행물

표지보기 관심저널 등록

• 간행물명

  한국임상약학회지 [Korean Journal of Clinical Pharmacy]

• 간기

  계간

• pISSN

  1226-6051

• 수록기간

  1991~2026

• 등재여부

  KCI 등재

• 십진분류

  KDC 518 DDC 615