China Drug Master File (DMF) Comparing with U.S. and EU

This session provides an overview of the Drug Master File (DMF) regulatory framework and registration pathways covering Active Pharmaceutical ingredients (APIs), Excipients and Packaging Materials. The aim is to provide an overview of the local requirements and advise on the best and quickest route to the Chinese market.

Thanks to the global harmonization efforts, the Chinese DMF regulatory system is becoming more similar with US DMF, EU ASMF and CEP requirements. However, local requirements and gaps in the regulations still exists, this session shares the registration procedures, timeline and costs of China DMF and further provides a comparison of China DMF with U.S. and EU from various perspectives.

Finally, this session shares the most common pitfalls in terms of technical requirements and provide hands-on tips to help minimize risks and issues with China regulatory authorities, and smooth DMF registration process in China.