ICH 技术指导原则概述--国家食品药品监督管理局--丁建华.pdfVIP

ICH 技术指导原则概述 ICH 技术指导原则概述 ICH Guidelines Introduction ICH Guidelines Introduction 国家食品药品监督管理局 丁建华 2009年12月12 日，北京 ICH Briefing ICH Briefing • Birth of ICH : April 1990, in Brussels • Main topics covers: Safety, Quality and Efficacy • Regions involved: Europe, Japan , USA • Purposes: to produce harmonized technical guidelines, reduce duplication • Model of function: dialogue between regulatory authorities and the pharmaceutical industry 1 ICH Structure ICH Structure • ICH Steering Committee: final decision maker for ICH guideline - EU and EFPIA EWG • 6 Parties - MHLW (PMDA) and JPMA IWG - FDA and PhRMA • 3 Observers: WHO, EFTA, and Canada (represented by Health Canada). • 6 RHIs: APEC, ASEAN, GCC, PANDRH, SADC ICH Working mechanism ICH Working mechanism • Concept paper proposed, EWG formed for each of the topic of Q, S and E • A 5-Steps decision-making model accepted from guideline initiation to implementation, Step 2 draft guidelines on web for comments till Step 4, final guideline approved by Steering Committee as final Step 5 guidelines • IWG established for implementation, QA on ICH Web for each guidelines • GCG established 1999, China SFDA first attended Oct. 23, 2009 2 ICH meetings ICH meetings • Usually internal experts meeting each ICH activity for a week, followed by a public meeting for updates until ICH 6 • ICH meeting hosted by US, JAPAN, EU in each Jun