Practical Law China Quotes Katherine Wang on China’s Drug Administration Law Draft

In Practical Law China’s May 2022 GC Agenda, life sciences regulatory & compliance partner Katherine Wang comments on China’s Drug Administration Law Draft, issued in May.

According to Katherine: "The draft, once promulgated as-is, will incentivize cross-border licensing transactions of innovative pharmaceutical products in both the early and late stages of clinical development. Once the pharmaceutical products are approved by the NMPA, the foreign marketing authorization holder may relocate the manufacturing operations to China and assign its marketing authorization to its Chinese licensee without initiating a time-consuming technology transfer process. In addition, regulatory exclusivity protections offered to new pediatric drugs, new orphan drugs and first-to-market generics will likely impact the competitive landscape."

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