2021.8.14(周六）上(shang)午九點鐘，輔料質(zhi)量(liang)聯盟舉(ju)辦《從按(an)照(zhao)新藥(yao)管理到(dao)按(an)照(zhao)仿(fang)制(zhi)(zhi)藥(yao)管理的(de)轉變》研討會，特(te)別(bie)約請北(bei)京凱瑞(rui)科(ke)德的(de)李老師進(jin)行專題講解。新的(de)藥(yao)品注冊管理辦法于2020年執行，揭開了仿(fang)制(zhi)(zhi)藥(yao)進(jin)口的(de)篇章。從今年5月到(dao)6月的(de)受理看，兩個知名國際(ji)仿(fang)制(zhi)(zhi)藥(yao)公司(si)加速了在中國的(de)進(jin)口申請—蘭迪博士的(de)西(xi)格列汀和(he)阿拉(la)賓度的(de)他達拉(la)非，而臨床時間(jian)花費極少。進(jin)口注冊已(yi)經不再要求100對臨床對照(zhao)和(he)PK 研究(jiu)。仿(fang)制(zhi)(zhi)藥(yao)的(de)生物等效(xiao)，就(jiu)成為了主旋(xuan)律。
本次(ci)線(xian)上研討會，全英文講解，研討會簡(jian)單介紹進(jin)口注冊的(de)(de)變化，案例展示在中國進(jin)行生物等效性(xing)試驗的(de)(de)執行合規(gui)化，國際化，請大家聆聽，并及時提出問題(ti)。
At 9:00 a.m. on August 14, 2021 (Saturday), the excipients manufacturing quality group will hold the webinar on Change: Generic IDL as "Generic" not "New Drug" and specially invite Mr. Li of Beijing Kcode Pharmaceutical R&D Inc. to give a special explanation.
The updated "drug registration stipulation" came into effect last year, which provoked the "generic import" stream. Dr. Reddy's and Aurobindo submitted two generics in May and June, with little cost in clinical trial. The IDL of preparation never go through 100 pair of clinical study and PK as the old regulation required. The BE is enough for most generic drugs now.
This webinar aims to show "how that" and how the BE is carried out. This webinar will be fully in English. Welcome to join in our webinar and discuss.