Authored by: Zhang Yunwei (Mark) , Yang Fan and Li Lingbi

Since the introduction of a nationwide Marketing Authorization Holder (MAH) system in 2019, licenses have linked directly to therapeutic products rather than manufacturers. This has cleared way for a new era where biotech companies (focused on R&D without manufacturing capability) can hold the market authorization while outsourcing the manufacture to contract manufacturing organizations (CMOs).

The MAH system has boosted the development of local biotech companies. Yet it is still unclear whether it is possible to have cross-border contract manufacture for both domestic and foreign players.

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