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…
Due to the US-China trade war, American delegates at Shanghai’s SIAL Food Expo decreased by 50% this year. No wonder China’s market has become more difficult for US firms when, for example, US wine tariffs are 70% (no FTA and trade war tariffs) while Australia’s are 0% (ChAFTA). On the latest Australia China Business Council…
Date: Tuesday, 12th May, 2020 Time: 13:30-14:30 CST (China Standard Time) Price: Free of charge Brought to you by New Zealand Trade and Enterprise (NZTE), this webinar series has been designed to help your business navigate the shifting digital landscape in post-COVID China. From mastering your digital strategy and optimising your social media investment, to…
On 16 July 2019, the China NMPA issued the Announcement on Further Improving the Binding Review, Approval and Supervision of Drugs (Announcement No. 56, 2019). This included updates to requirements for the filing and binding review of APIs, excipients, and pharmaceutical packaging materials. With this new announcement, Announcement No. 146, 2017 will be…
China has implemented a separate filing and review regime with drug products since December 2017. This was announced in the publication “Announcement on adjusting the review and approval system of drug substance, pharmaceutical excipients and pharmaceutical packaging materials (No. 146, 2017)” by CFDA (the new rule was published as Announcement No. 56, 2019). …
China has implemented a separate filing and review regime with drug products since December 2017. This was announced in the publication “Announcement on adjusting the review and approval system of drug substance, pharmaceutical excipients and pharmaceutical packaging materials (No. 146, 2017)” by CFDA (the new rule was published as Announcement No. 56, 2019). …
