Zhengyu Wu

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Novo Nordisk (China) Pharmaceuticals
Regulatory Affairs Director
Zhengyu “Zero” Wu is Regulatory Affairs Director at Novo Nordisk (China) Pharmaceuticals. With 16 years of experience in drug regulatory affairs, he has long been engaged in registration of innovative products, life cycle management of marketed products, regulatory intelligence, and CMC support. Prior to Novo Nordisk, he worked at Eli Lilly and Baxter. He serves as member of the CMC committee on the R&D-Based Pharmaceutical Association Commit-tee (RDPAC) and is a research fellow at Yeehong Business School of Shenyang Pharmaceutical University, dedicated to research and strategy development on Chinese drug regulations. He holds an MS in pharmacology and a JM in international economic law.

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Evolving China’s Regulatory System in Alignment with ICH

With the Chinese government initiating drug regulatory reform in 2015 and China joining the International Council for Harmonisation (ICH) in 2017, a significant number of measures have been implemented by the government. The aim is to make fundamental changes to China’s drug regulatory administration system so it can facilitate pharmaceutical development and better meet patient needs in the...