New Guideline for Drug Master Filing (DMF) in China
China DMF Inactive Number by CDE. Complete but not approved. China DMF Active Number by CDE. Activated/Approved. For Drug master filing (DMF) in China, there is a new guideline released by China’s NMPA (Formerly CFDA) in 2019 for the scope of active pharmaceutical ingredients (APIs), excipients and packaging materials. Similar to the systems of…