Topic: An overview of the China NMPA organization and the history of regulatory reform
Summary: Since 2015, the China pharmaceutical landscape has been experiencing reform initiated by the central government in order to promote a focus on unmet medical need. Many laws, regulations, announcements and guidance have been published covering R&D, regulatory submission and approval, lifecycle management, Marketing Authorization Holders, sales and distribution, as well as supervision. This session will introduce the NMPA organization and the history of reform, to help us better understand the China regulatory landscape.
Speaker: Gerald Li (（李军） Regulatory Affairs Director, Elixir Clinical Research
Date: Monday May 16 @ 8 pm EDT/5 pm PDT
Location: Virtual - see zoom information below
Sponsored by the DIA Regulatory Affairs Community, Regulatory Intelligence WG as part of a series of sessions on the China Regulatory Environment as presented by the China Regulatory Affairs Community (RAC)
Open to all DIA members
https://diaglobal.zoom.us/j/99796670995?pwd=NDhHZFJxcWl6VUpsVGNCbU9TcEFpdz09
Meeting ID: 997 9667 0995
Passcode: 670992
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https://diaglobal.zoom.us/j/99796670995?pwd=NDhHZFJxcWl6VUpsVGNCbU9TcEFpdz09
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