China pharmacovigilance regulations have been undergoing significant reform reinforced by recently issued Good Pharmacovigilance Practices (GVP) (2021, Decree No. 65). In addition to the regulations, the National Medical Products Administration (NMPA), Center for Drug Evaluation (CDE) and National Centre for Adverse Drug Reaction (ADR) Monitoring (NCADRM) of China have also released guidelines and standards for…
China Drug Master File (DMF) for APIs, packaging Materials, and pharmaceutical excipients are regulated by China NMPA formerly CFDA. The related DMF regulations and standards clarify the drug master file structure, process, requirements, timelines, and costings in the regulations listed below. Contact Accestra Consulting Group for English translations or questions on China’s Drug Master File…
Animal testing is conducted on animals such as rabbits (usually in Chinese labs) and guinea pigs. This is toxicological testing for reactions such as eye irritation or skin irritation, A majority of overseas brands from Europe, America, Australia, and New Zealand are cruelty-free and don’t do animal testing. But China, as a huge…
Date: Tuesday, 9th March, 2021 Time: 7:30 AM – 8:30 AM CST (China Standard Time) Price: Free of charge Click here to register. You will then receive an invitation to this webinar. Please note that the number of participants is limited. TOPICS and SPEAKERS: Pete Frost: Trade Commissioner, Greater China, New Zealand Trade & Enterprise…
Accestra Consulting Group has put together the top 10 most asked questions and answers to China’s clinical trial exemption and IND application (CTA). China’s Center for Drug Evaluation (CDE) allows a drug Marketing Authorization Holder (MAH) to apply for clinical trial exemption in China if a drug is already approved for marketing in…
Join free webinar on China Drug Master File (DMF) Filing for APIs, Excipients & Packaging Materials (click here to register) on Thursday 15th April, 2021, at 10:30 CEST time. The webinar will provide an overview of the requirements, regulatory pathways, how to register your DMF in China and a comparison between US FDA and EMA…
Before 2018, the Pharmacovigilance (PV) System in China was still in its early days. Companies’ activities to drug safety were for the most part passive. Then market authorization holder (MAH) was put in place to report on adverse drug reactions (ADR). As a result, in 2019 China included the provision of “establishing…
