Earticle

초록

영어

Nonprescription drugs have become increasingly important in Korean healthcare. By leveraging lower-cost drugs and reducing expenditure associated with fewer physician visits, the nonprescription segment can deliver tremendous value to individual consumers and the Korean healthcare system. Many countries have provided simpler and more rapid routes to market entry for qualifying nonprescription drug products, using the established data on drug safety and efficacy, as well as public and professional opinion. In US, the FDA waived the pre-approval process for over-the-counter (OTC) drugs marketed through the OTC Monograph Process. In Australia and Canada, different OTC product application levels are defined, with a reduced level of assessment required when the risks to consumers are considered low. Japan established a new OTC evaluation system in 2014 to facilitate the Rx-to- OTC switch process. The legislative framework for medicinal products in the European Union allows for drugs to be approved with reference to appropriate bibliographic data for old active substances with well-established uses. Through a comparison of the regulatory framework and the requirements for nonprescription approval process in different countries, several ways to improve regulatory practice for the evaluation of nonprescription drugs in Korea have been suggested.

목차

ABSTRACT
연구 방법
연구 결과
국내
일본
미국
유럽연합
영국
캐나다
호주
고찰 및 결론
감사의 말씀
참고문헌

키워드

저자

• 김주희 [ Joo Hee Kim | 이화여자대학교 약학대학, 아주대학교 약학대학 ]
• 이정 [ Jeong Yee | 이화여자대학교 약학대학 ]
• 이관영 [ Gwan Yung Lee | 이화여자대학교 약학대학 ]
• 이경은 [ Kyung Eun Lee | 충북대학교 약학대학 ]
• 곽혜선 [ Hye Sun Gwak | 이화여자대학교 약학대학 ] Corresponding Author

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