Transcription of New CFDA Requirements and its Implementation
{{id}} {{{paragraph}}}
Example: marketing
New CFDA Requirements and its Implementation
New CFDA Requirements and its ImplementationYi Yang, Senior Principal ProgrammerSep 4, 2018 PharmaSUGS ingle Day EventTokyo, JapanGlobal Drug DevelopmentDisclaimer All information provided in this slides is provided for information purposes only Views expressed in this presentation are those of the speaker and not necessarily of Novartis2 Global Drug DevelopmentBiography Yi (Eason) Yang joined Novartis in 2010 and is currently Senior Principal Programmer3 Global Drug DevelopmentCFDA or Food and Drug PresentChinaNational Drug Administration4 Global Drug DevelopmentAgenda5 CNDA ReformNew Guidance & GuidelinesEntresto CNDA Submission Case StudySummaryCNDA ReformGlobal Drug DevelopmentRegulatory Environment Before ReformChallenging Lengthy and unpredictable review timeline Additional regulatory Requirements Unclear technical Requirements CDE resource issue Lack of connection among different authorities bodiesInconsistent with global standards Local standards Local clinical data Local quality testing during CTA and NDA More CMC data Overseas marketing requirements7 Global Drug DevelopmentCNDA Reform8 China State Council approved Opinions on Reformingthe Evaluation and Approval System for Drugs and Medical Devices and was formally announced to the public on August 9.
New CFDA Requirements and its Implementation Yi Yang, Senior Principal Programmer Sep 4, 2018 PharmaSUG Single Day Event Tokyo, Japan
Loading..
Information
Domain:
Source:
Link to this page:
Please notify us if you found a problem with this document: