Strategic Biopharma Regulatory Approaches for China

May 21, 2019 8:00 AM - 10:00 AM

MassBio, 300 Technology Square 8th Fl, Cambridge, MA 02139

China is the second largest biopharmaceutical market in the world, just behind the US. Its demand for medicines is growing fast and the government has been aggressive in implementing change. Therefore the Chinese market is becoming increasingly more of a strategic priority for foreign companies. Fast changing regulatory reforms by the CDA aim to accelerate the regulatory review process so new products can be launched to meet patient’s needs. This forum will provide the latest updates on Chinese regulatory policy reform for the biopharma regulatory professional. Our panel will share their experiences and suggest strategic approaches to optimize your company’s regulatory strategies and pathways in China. Coverage will include: CDAs approach to rare diseases and accelerated pathways; new things to know about the CTA application, NDA/BLA and much more.