Home » China Lays Down Pilot Plan for Marketing Authorization System
China Lays Down Pilot Plan for Marketing Authorization System
China has released details of a pilot program that extends drug product licensing to domestic research and development institutions and their personnel.
Previously, only drug manufacturers could commercialize a drug in the country. The pilot also allows license holders to outsource their manufacturing operations to GMP-certified contract manufacturers, according to law firm Ropes & Gray.
Specifically, the program makes R&D companies in piloted regions eligible for drug product licenses.
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