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This webinar is part of a series of 4 webinars on Regulatory Affairs in China.

Marketing authorization application (MAA) in China
Date: 05.07.2019
Time: 15.00 - 16.00 CET
Duration: 60 mins
Lecturer: Yingying Liu

Agenda
  • MAA pathways overview, including the fast MAA approval
  • MAA dossier preparation highlights, CMC requirements
  • Master file bundling review: Requirements for the Application Data of API, excipients and packaging materials
  • Marketing authorization holder system, overseas inspection overview
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