This session reviews the latest updates and current landscape in China for medicinal products, including advanced therapies.
First we will look at the what: what are recent regulation changes of note in China? What is the current landscape and future expected direction? What are latest timelines for different drug types, and how to fast-track? What about alternative access pathways especially Hong Kong into the Greater Bay Area region, and recent data here?
Then we look at the how: how to integrate China into a global perspective? How we can focus on the science and patient need?
A short panel at then end will include discussion of some case studies and examples as well as time for Q&A.
Learning Objectives:
describe the latest updates and requirements for regulatory submissions of medicinal products at China's NMPA
explain strategic options of integrating China into global drug development
explore case studies and examples about China submission approvals
.jpg "Xiao Michelle Meng, PhD photo")