加强新药审批PMDAsEffortstostrengthenNewDrugReview.PDF

加强新药审批 PMDA’s Efforts to strengthen New Drug Review - 加快审批速度 - - How we accelerate reviewing speed - 依田纪彦 Norihiko YODA,MD 日本医药品及医疗器械管理机构新药三部部长 Director, Office of New Drug III, PMDA, Japan May 23, 2012 Shanghai, China 1 Disclaimer • The views and opinions expressed in the following PowerPoint slides are those of the individual presenter and should not be attributed to Drug Information Association, Inc. (“DIA”), its directors, officers, employees, volunteers, members, chapters, councils, Special Interest Area Communities or affiliates, or any organization with which the presenter is employed or affiliated. • These PowerPoint slides are the intellectual property of the individual presenter and are protected under the copyright laws of the United States of America and other countries. Used by permission. All rights reserved. Drug Information Association, DIA and DIA logo are registered trademarks or trademarks of Drug Information Association Inc. All other trademarks are the property of their respective owners. 2 4th DIA China Annual Meeting: Collaboration and Innovation in China May 20-23, 2012 | Shanghai, China 古代中国（三皇五帝的时代） 现代日本 Ancient China Present Japan 神农尝百草调查是毒还是药 PMDA审查医药的有效性调查安全性 Shennong used to judge the poison or the PMDA examines the effectiveness of the medicine by tasting various grasses. medicine and investigates safety. 4th DIA China Annual Meeting: Collaboration and Innovation in China May 20-23, 2012 | Shanghai, China The 4th DIA China Annual Meeting: Collaboration and Innovation in China Event Name, Location May 21-23, 2012 | Shang