의약품의 시판후 조사제도 비교연구

Abstract

The adverse events which do not appear in the approval process tend to occur more frequently at the earlystage of the use. Therefore new drugs, drugs with different active substances or routes of administration, or drugs withexplicitly different efficacy added are particularly chosen for re-examination, and go through a study, which is conducted on600 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-exam-ination as of until March 2005. Post Marketing Surveillance to insure drug safety should be corelated with re-examinationof new drug, re-evaluation of drug, and adverse event monitoring system. And the first labeling change should reflect allinformation collected for a defined period of time after the marketing authorization is granted. Furthermore, centralizedtype of system.Keywords . adverse event, Post-Marketing Surveillance system, re-examination