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从按照新药管理到按照仿制药管理的转变

编辑:北京凯瑞科德     时间:2021-08-10       浏览量:

2021.8.14(周六)上午九点钟,辅料质量联盟举办《从按照新药管理到按照仿制药管理的转变》研讨会,特别约请北京凯瑞科德的李老师进行专题讲解。新的药品注册管理办法于2020年执行,揭开了仿制药进口的篇章。从今年5月到6月的受理看,两个知名国际仿制药公司加速了在中国的进口申请—兰迪博士的西格列汀和阿拉宾度的他达拉非,而临床时间花费极少。进口注册已经不再要求100对临床对照和PK 研究。仿制药的生物等效,就成为了主旋律。
本次线上研讨会,全英文讲解,研讨会简单介绍进口注册的变化,案例展示在中国进行生物等效性试验的执行合规化,国际化,请大家聆听,并及时提出问题。
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.

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