Drug Marketing Approval Pathways in China: 2023 Latest Updates, Accelerated Pathways & Market Challenges

China has been dedicated to drug registration reform to simplify application procedures and integrate with international regulations since China joined ICH in 2017. While convergence continues, there are still noteable differences with other major markets. There is frequently a clear lack of information and guidance in English for China as compared with US or EU regulations, SOPs and quality requirements.
This session presents advisory and industry perspectives on China marketing approval latest regulatory updates, accelerated pathways and market challenges for chemical and biological drugs (including China DMF of APIs, excipients and pharma packaging), administration fees, application timelines, and offer tips for submission dossiers and approval. The latest fast-track possibilities and accelerated timelines will be discussed to expedite the registration procedures for urgent clinical use drugs, rare diseases drugs, pediatric drugs, urgent use vaccines, breakthrough therapy drugs and others, as well as key roadblocks and practical tips during the session.