Good news: on October 14th, China’s National Medical Products Administration (NMPA) has announced an extra 80 to 160 days extension for the submission of drug supplementary dossiers to China’s Center for Drug Evaluation (CDE) for drug registration (No. 86 of 2022). The temporary extension of the timeline for submission of supplementary materials for drug registration…
In 2021, China’s Center for Disease Evaluation (CDE) has rejected 542 drug registration applications. 359 rejected applications were due to failure of submitting supplementary dossiers in time (hereinafter “Exceed Deadline”), accounting for 66.3% of all rejected applications. The overdue cases included applications of 9 Traditional Chinese Medicine (TCM), 349 chemical drugs, and 1 biological product.…
The newly released 2021 Drug Review Annual Report by China’s Center for Drug Evaluation (CDE) of National Medical Products Administration (NMPA) data shows that China has achieved doubling of drug approvals in 2021 compared to prior year. More importantly, it suggests the determination of Chinese authority to encourage more New Drugs to the market by…
The beginning of June has seen the release of 2021 Drug Review Annual Report by China’s Center for Drug Evaluation (CDE) of National Medical Products Administration (NMPA). In 2021, the drug review work has achieved new records by accomplishing 47 innovative new drug approvals. In addition, the completion rate of on-time review & approval of…
On June 7, 2022, the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) released the Annual Report on Progress of Clinical Trials for New Drug Registration in China (2021). CDE and NMPA’s annual report represents a comprehensive summary and analysis of clinical drug trials for new drugs within the last 3…
Accestra will be presenting at the webinar “China’s OTC Drug Market – Growth Potentials” hosted by the U.S. Commercial Service in China Date and Time: Wednesday, 15th June, 2022, 4:00-5:10PM (Pacific Time), 8:00-9:10PM (Eastern Time) Thursday, 16th June, 2022, 8:00-9:10AM (Beijing Time) COST: USD25 per participant Click here to register. You will then receive an…
Topic: China Drug Master File (DMF) Filing Agenda: Regulatory Framework & Registration Comparison among China, EU & US Common Challenges Questions and Answers Date and Time: 25th May (wed) 5:00-6:00 pm China time Time: Jun 9, 2022 10:30 AM in Paris Speakers
What’s new for Good Pharmacovigilance Practices (GVP) in China In collaboration with Pharma to Market, join us for a series of two complimentary webinars as we give you an introduction into the latest policy updates on the Good Pharmacovigilance Practices (GVP) in China, Singapore & Malaysia in the final week of May 2022. What’s new…
