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.