Meng Yang, PhD

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Roche
Technical Regulatory Policy China Lead
Meng Yang, PhD, is Technical Regulatory Policy China Lead at Roche. Meng joined Roche in October 2019 as Technical Regulatory Policy China Lead, responsible for China’s technical regulatory policy influencing and shaping. Prior to joining Roche, Meng worked at Hubei Food and Drug Administration and National Medicinal Products Administration as an inspector and a biologics CMC reviewer and was an expert working group member of the CDE’s ICH Q5A working group, with seven years of experience in biologics quality assessment and inspection. Meng graduated from Xiamen University in 2012 with a PhD in molecular cell biology. Her research interests include hepatocellular liver cancer progression mechanism and mesenchymal stem cell differen-tiation mechanism.

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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...