|
KMID : 1142220060010020039
|
|
Regulatory Research on Food, Drug & Cosmetic
2006 Volume.1 No. 2 p.39 ~ p.42
|
|
|
The Present Situation and the Direction of Improvement of Post-Marketing Surveillance in Korea
|
|
Shin Joon-Su
|
|
|
Abstract
|
|
|
|
The aim of post-marketing surveillance (PMS) is to identify the factors related to safety and efficacy which could not be found in a pre-marketing phase (e.g. clinical trial) and to take administrative measures for safer and rational drug use. At present, PMS systems such as‘ Spontaneous Adverse Drug Reaction (ADR) Monitoring System’,‘ the Re-Evaluation of the Drugs’, and ‘the Re-Examination of the New Drugs’are being administered in Korea. Spontaneous ADR monitoring is to collect case reports and to detect signals from them through scientific evaluation and to take appropriate actions (e.g. to include signals in the label). Korea Food & Drug Administration (KFDA) will make efforts continually to increase the number of spontaneous ADR reports and to develop drug-ADR causality assessment method and will also proceed the manpower reinforcement. And KFDA will improve the Re-Evaluation system of the drugs in the direction of strengthening clinical evaluation like biological equivalence test. For the purpose of improving the effectiveness and reliability on the Re-Examination of the new drugs, KFDA will consider the adjustment of timeline in reporting ADR cases and introduction of the investigation etc.
|
|
|
KEYWORD
|
|
|
Pharmacovigilance, Post-Marketing Surveillance (PMS), ADR Monitoring, the Re-evaluation of the drugs, the Reexamination of the new drugs
|
|
|
FullTexts / Linksout information
|
|
|
|
|
|
Listed journal information
|
|
|
|