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…
In 2019, the Center for Drug Evaluation (CDE) of China reviewed and approved a total of 8730 drug registration applications. As a follow-up on part 3 of Drug Evaluation Report 2019, part 4 further gives an overview of new drug approvals for hot topics in drug therapy and major regulatory events/reforms of 2019 summarized by…
In 2019, the Center for Drug Evaluation (CDE) of China reviewed and approved a total of 8730 drug registration applications. As a follow-up on part 2 of Drug Evaluation Report 2019, part 3 further gives an overview of drug approvals for all application types (incl. IND registrations), drug priority review & accelerated approvals, and drug…
China Drug Master File Overview The scope of China Drug Master File (DMF) filing covers: Active Pharmaceutical Ingredients (APIs), Pharmaceutical excipients and packaging materials. The registration approval by China Food and Drug Administration (CFDA) was replaced with a new DMF filing system. It requires overseas manufacturers to appoint an authorized agent in China for product…
In 2019, the Center for Drug Evaluation of China reviewed and approved a total of 8730 drug registration applications. As a follow-up on part 1 of Drug Evaluation Report 2019, part 2 gives an overview of technical review and approval of these registration applications, and an analysis of those approved under each registration classification, including…
The 2020 Edition of the Pharmacopoeia of the People’s Republic of China (hereinafter referred to as 2020 Chinese Pharmacopoeia) has been issued by NMPA and NHC Announcement, and shall come into force as of December 30, 2020. Read Chinese Pharmacopoeia 2020 Edition: Key Points On July 3, NMPA hereby announced the following matters concerning the…
In 2019, the Center for Drug Evaluation (CDE) in China approved a large number of registrations for drug products as well as drug-device combinations. The majority of drug registrations required technical review and approval, whereas the others required only administrative approval. The number of different registrations approved by China CDE in 2019 is listed in…
