Time and Location: 24 – 25 May 2023 | London, UK Meet us in London, engage with our speaker face to face about China GVP and relevant regulation changes and get real-time feedback for your questions. INTRODUCTION Pharmacovigilance regulations in China are constantly evolving and rapidly changing. With China becoming increasingly important for pharmaceutical companies,…
Accestra Webinars In collaboration with Pharma To Market, we invite you to join us for a complimentary webinar on 17th April 2023. Registration of Drug Master File (DMF) in China for APIs, Excipients & Packaging Materials The China DMF registration webinar will cover these topics: China DMF Regulatory Framework China DMF Pathways Comparison between China…
Click To Download/Read The Full Q&A Content Click To Download The Slides Q1: If have integral DDC product with lots of device (packaging) info in Modules 3.2.P.2.4 & P.7 can you simply x-ref to these sections for safety, tesing/CoA’s, stability etc. A1: Considering the definition of DDC product in China could be different with other…
ACCESTRA WILL BE PRESENTING AT THE WEBINAR “COMPARISON OF CHINA DMF WITH EU AND US” ON TOPRA. Date: 22 Feb 2023, Wednesday Time: 15:00-16:00 GMT 10:00-11:00 Eastern Time Date: 22 Feb 2023, Wednesday Time: 23:00-24:00 Beijing Time Webinar Introduction This webinar is about China Drug Master Filing (DMF) versus EU and U.S DMF. Accestra will…
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’…
Signal management in Pharmacovigilance is an important part in China’s Good Pharmacovigilance Practice (hereinafter “China GVP”), which was released by National Medical Products Administration (NMPA) in May 2021. “To conduct efficient activities of signal detection and assessment” is listed as a fundamental requirement for quality management in Pharmacovigilance and one of the key responsibilities of…
On December 19, 2018, China’s NMPA released the Guideline for Collecting and Reporting of Individual Case of Adverse Drug Reactions (hereinafter “the Guideline”). Aiming to standardize the collection and reporting throughout the Adverse Drug Reaction (hereinafter “ADR”) monitoring and processing, this Guideline provides for the Market Authorization Holder (MAH) a “5+3” instruction —5 consecutive procedures…
NMPA News: China’s National Medical Products Administration (NMPA) has released for public comments a draft announcement on administration of registration renewal of chemical active pharmaceutical ingredients (APIs) in early November. It is expected that the official announcement will be finalized soon and will facilitate the Drug Master File (DMF) process in China in future. According…
