•CertificationofsuitabilitytothemonographsoftheEuropeanPharmacopoeia •Procedure,SubmissionoftheDossier,ContentoftheDossier/ExpertReport,Assessment,Timetable,Follow-up 技术要求 •CTD格式的EDMF的编撰:•a)模块3.2.S.药物物质•b)模块2.3质量概述 •CEP程序对DMF程序 •在欧盟国家的文件编撰策略 •...