採用證明.pptVIP

Nov-17-2008 TGCC 新藥查驗登記經驗分享 NDA – New Drug Application Outlines Definition of New Drug 西藥查驗登記手冊 Guidance for Drug Registration General Requirements for a NDA in Taiwan 出產國許可製售證明 可代替出產國許可製售證明之文件 採用證明 採用證明 (公定書) 特別規定 - 檢附出產國許可製售證明 採用證明 General Requirements for a NDA in Taiwan General Requirements for a NDA in Taiwan General Requirements for a NDA in Taiwan What shall be done before/during NDA?  Thank You for Your Attention! * * 曾 淑 貞 Nov/17/2008 Definition of New Drug ex DOH Guidance for Drug Registration General Requirements for a NDA in Taiwan What else shall be done