The biopharmaceutical industry is rapidly growing, with about half of the growth in emerging markets. The goal of a biopharmaceutical company is to build a sustainable, cost-efficient supply chain while meeting global regulatory requirements. In particular, launching innovative drug products in China presents a unique set of challenges.
In this webinar, we will discuss the differences and commonalities among major global agencies, including US FDA, EMA, and China NMPA. Building upon that, we will discuss approaches to build a robust data package that satisfies expectations from global health authorities for clinical and commercial regulatory filings. We will share real-world case studies of how WuXi STA supported clients with their China filing strategies and expedited development and commercialization in China.