국내외 의약품 유익성-위해성 평가 기법에 대한 고찰

Abstract

The development of systematic and structural tool evaluating drug Benefit-Risk Assessment (BRA) has long been a hot issue in pharmaceutical and regulatory division worldwide. It has been proposed to conduct drug BRA during the whole drug life due to the unknown adverse events by long term drug use or unconfirmed drug efficacy and safety in specific groups of people by the golden rule of drug approval evidence, randomized controlled trials being widely comprehended. We aimed to collect and review BRA tools and strategies in the advanced countries, international organizations, and Korea in order to get the trends and knowledges of BRA to advance the BRA system in Korea. ICH and WHO did not support a specific BRA model but stated the basic principles and formats. EMA & IMI conducted a rigorous project to present and suggest quantitative and qualitative BRA methods. They highlighted using ProACT-URL and Effects Table in regulatory decision process and suggested to utilize quantitative Multiple Criteria Decision Analysis in BRA. FDA suggested simple and qualitative approach of Benefit Risk Framework (BRF), in the concern of potential bias induced by quantitative approach. Korea also has been following up the advanced BRA tools consistently but requires establishment of localized BRA strategy satisfying its own perspectives. From these contexts, Korea needs to build up a task force or tangible environment to actively discuss and implement BRA tools.