藥事法規(guī)與新藥注冊總論(20150922)

1、1 Tel39943092 E-mail: 2 3 4 5 6 7 8 9 To legally gather this data on safety and effectiveness in the U.S., the maker must first obtain an (IND) designation from FDA. The documentation required in an NDA is supposed to tell the drugs whole story, including what happened during the clinic

2、al tests, what the ingredients of the drug formulation are, the results of the animal studies, how the drug behaves in the body, and how it is manufactured, processed and packaged. Once approval of an NDA is obtained, the new drug can be legally marketed starting that day in the U.S. 10 Initial New

3、Drug (IND) Application MedicalPharmacology/ ToxicologyCMCStatistics Decision Reached and Returned to the Company in 30 Days No Response (permission to proceed) Request for more information OR Clinical Hold OR 11 12 13 14 ， 15 Q Quality Topics, i.e., those relating to chemical and pharmaceuti cal Qua

4、lity Assurance (Stability Testing, Impurity Testing, etc.) S Safety Topics, i.e., those relating to in vitro and in vivo pre- clinical studies (Carcinogeni city Testing, Genotoxicity Testing, etc.) E Efficacy Topics, i.e., those relating to clinical studies in human subject (Dose Response Studies, G

5、ood Clinical Practices, etc.) M Multidisciplina ry Topics, i.e., cross- cutting Topics which do not fit uniquely into one of the above categories (MedDRA, ESTRI, M3, CTD, M5) 16 ： 。 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 v鼓勵創(chuàng)制新藥，在制度上創(chuàng)新、審評上優(yōu)先、程鼓勵創(chuàng)制新藥，在制度上創(chuàng)新、審評上優(yōu)先、程 序上簡化、

6、技術(shù)上溝通，真正形成有利于激發(fā)創(chuàng)序上簡化、技術(shù)上溝通，真正形成有利于激發(fā)創(chuàng) 新活力的審評審批機(jī)制新活力的審評審批機(jī)制 v積極探索上市許可人制度試點(diǎn)，實(shí)行藥品上市許積極探索上市許可人制度試點(diǎn)，實(shí)行藥品上市許 可與生產(chǎn)許可分開管理；可與生產(chǎn)許可分開管理； 40 41 v“四個最嚴(yán)四個最嚴(yán)”： 建立最嚴(yán)謹(jǐn)?shù)臉?biāo)準(zhǔn)建立最嚴(yán)謹(jǐn)?shù)臉?biāo)準(zhǔn)，標(biāo)準(zhǔn)要全面、科學(xué)、符合實(shí)際，標(biāo)準(zhǔn)，標(biāo)準(zhǔn)要全面、科學(xué)、符合實(shí)際，標(biāo)準(zhǔn) 要及時修訂；要及時修訂； 實(shí)施最嚴(yán)格的監(jiān)管實(shí)施最嚴(yán)格的監(jiān)管，嚴(yán)格受理審查、現(xiàn)場核查、抽樣檢驗(yàn)、，嚴(yán)格受理審查、現(xiàn)場核查、抽樣檢驗(yàn)、 藥品再注冊工作；藥品再注冊工作； 實(shí)行最嚴(yán)厲的處罰實(shí)行最嚴(yán)厲的處罰，落實(shí)藥品研發(fā)、生產(chǎn)、流通、使用各，落實(shí)藥品研發(fā)、生產(chǎn)、流通、使用各 環(huán)節(jié)的企業(yè)主體責(zé)任，嚴(yán)厲處罰檢查中發(fā)現(xiàn)的違法行為，環(huán)節(jié)的企業(yè)主體責(zé)任，嚴(yán)厲處罰檢查中發(fā)現(xiàn)的違法行為， 做好執(zhí)法結(jié)果公開工作；做好執(zhí)法結(jié)果公開工作； 落