张明平PPT-不同研发阶段中美双报药学资料的准备#U00a0.pdf

论坛43期活动 不同研发阶段中美双报药学资 料的准备 张明平 PAREXEL Consultant Principal Consultant 张明平 首席咨询员 •现任精鼎医药研究开发（上海）有限公司首席 咨询员 • 国际制药工程协会(ISPE)中国法规委员会主席 •前百济神州CMC高级总监，管理创新药物研发过 程中的药学相关事务； •前中国外商投资企业协会药品研制和开发行业委 员会 （RDPAC）CMC专业组委员会成员 •前诺华DRA CMC高级经理；负责所有与中国申 Zhang Mingping 报相关的药学事务； Principal Consultant •前国家药监局药学审评员，曾负责外科，心血管， PAREXEL International 抗生素等药物的药学审评； EARLY STAGE - CONSULTING •新加坡国立大学化学工程硕士 •北京化工大学生物化学工程学士 大纲 CMC 介绍 早期临床申请 CTD及一般药学申报要求 China – Regulatory Requirements Practice Moving to ICH Alignment Current situation: • Regulatory Reform (currently change from conservative to more aggressive attitude: International Standard – quality Science) •Technical perspective: Information spread across several laws, regulations and guidelines; Written requirements are not always very clear and do not cover all relevant aspects; Executed practice does sometimes fill gaps in written regulation (but can change without prior notice) CMC 介绍 CMC是什么 Chemistry Manufacturing Clinical Control • WIKI: Chemistry, Manufacturing, and Controls (CMC) Pre-clinical constitutes that part of pharmaceutical development that deals with the nature of the CMC