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…
China pharmacovigilance inspection is a critical part for ensuring enforcement of patient safety systems. On April 15 of 2022, China NMPA has released theGuideline for Pharmacovigilance Inspection [No. 17 of 2022]. It requires that the authority and institutions conducting the inspection shall follow the regulations in Measures for the Administration of Drug Inspection (Trial) [No.…
On October 31st, China’s National Medical Products Administration (NMPA) announced with immediate effect the suspension of import, sales, and use of Dutasteride Soft Capsules by GlaxoSmithKline (GSK). (See the original announcement here.) According to the NMPA announcement, during the on-site inspection, GSK failed to comply with China’s regulatory requirements. The inspection found that the company…
Ever since the World Health Organization (WHO) defined “Pharmacovigilance” as “the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other possible drug-related problems” in 2002, the concerns of pharmacovigilance have kept widening. To date, aspects including herbals, traditional and complementary medicines, blood products, biologicals, medical devices, and…
