A Guide to Drug Master File (DMF) Filing in China
For pharmaceutical companies aiming to enter the Chinese market, understanding the Drug Master File (DMF) process for Active Pharmaceutical Ingredients (APIs), excipients, and packaging materials is essential. The China DMF provides crucial details about the quality, safety, and efficacy of these components, making it a key requirement for drug product registration in China. What is […]
China CDE Q&A on DMF Filing and Drug Application’s Electronic Submission (Mar 3rd 2023)
China Center for Drug Evaluation (CDE) published six questions and answers on 3rd Mar. The Q&As are regarding drug master file (China DMF) filing (Q1-Q2) and electronic submissions for drug applications (Q3-Q6). Accestra provided English translations of the Q&As. In the event of any inconsistencies between the translated text and the original Chinese version, the […]
CHINA CDE EYES MORE DRUG APPROVALS BY 2025
China CDE director vows more support for drug review & approval in the coming years. The director of China’s Center for Drug Evaluation (CDE) has delivered a speech on Improving the Efficiency and Quality of Drug Review & Approval at the 2022 DIA China Annual Conference, with a retrospective summary of the last 5 years’ work and […]