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 […]