의약품의 시판 후 조사제도 비교

• 영문명: The Comparative Study on Post-Marketing Surveillance System for Pharmaceuticals
• 발행기관: 대한약학회
• 저자명: 김인범(In Beom Kim) 김홍진(Hong Jin Kim) 손의동(Uy Dong Sohn)
• 간행물 정보: 『약학회지』제50권 제3호 (2006년), 145~153쪽, 전체 9쪽
• 주제분류: 의약학 > 기타의약학
• 파일형태: PDF
• 발행일자: 2006.06.30

영문 초록

The adverse events which do not appear in the approval process tend to occur more frequently at the early stage of the use. Therefore new drugs, drugs with different active substances or routes of administration, or drugs with explicitly different efficacy added are particularly chosen for re-examination, and go through a study, which is conducted on 600 to 3,000 subjects over 4 to 6 years. Since the re-examination system was implemented in January 1995, 880 drug prod- ucts have been designated as the subject of re-examination and among them 194 drugs have been completed their re-examination as of until March 2005. Post Marketing Surveillance to insure drug safety should be correlated with re-examination of new drug, re-evaluation of drug, and adverse event monitoring system. And the first labeling change should reflect all information collected for a defined period of time after the marketing authorization is granted. Furthermore, centralized management through spontaneous reporting system of adverse event for whole period of time would be the most desirable type of system.

키워드

adverse event Post-Marketing Surveillance system re-examination