On August 20th, China State Medical Insurance Administration issued the 2019 version of the National Reimbursement Drug List (for Basic Medical Insurance, Work Injury Insurance and Maternity Insurance). The general composition of the list is as follows: The newly added drugs include the drugs listed in the National Essential Drug List, drugs to treat cancer…
On July 31st, China CDE has published 7 Questions and Answers on biosimilar development to industry on its website. It mentioned that these Q&As respond to the most-commonly-asked-questions from applicants, and these Q&As also describe CDE’s considerations and requirements. Q4: Consideration in immunogenicity assessment A4: Sponsors are encouraged to collect immunogenicity data in any clinical…
On July 31st, China CDE has published 7 Questions and Answers on biosimilar development to industry on its website. It mentioned that these Q&As respond to the most-commonly-asked-questions from applicants, and these Q&As also describe CDE’s considerations and requirements. Q1: The scope of ‘biosimilars’ A1: ‘Biosimilars’ applies to the therapeutic recombinant protein products with a…
The information published on China CDE public platform showed that there are 8 innovative drug (Class 1) IND applications accepted by CDE on the day Aug 1st, 2019. According to the new classification system for chemical drugs lunched by China former CFDA since 2016, Class 1 new drugs are defined as “innovative drugs that contain…
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). …
On 2nd July, 2019, China CDE-NMPA published the 2018 working Report, summarizing the drug review and approval statistic data in the past year. See below for the details. 8- Statistic of Traditional Chinese Medicine – Overall 9- Statistic of Traditional Chinese Medicine -IND 10- Statistic of Traditional Chinese Medicine -NDA
On 2nd July, 2019, China CDE-NMPA published the 2018 working Report, summarizing the drug review and approval statistic data in the past year. See below for the details. 5- Statistic of Biological Products – Overall 6- Statistic of Biological Products -IND 7- Statistic of Biological Products -NDA
