2017 Annual Statistical Report on Food and Drug Supervision Released

Apr. 27, 2018

On April 3, 2017, CFDA published the 2017 Annual Statistical Report on Food and Drug Supervision, which is excerpted as follows: Drug registration As for new drug review and approval, in 2017, a total of 734 applications for clinical trials of INDs have been approved, along with 20 new drug certificates plus approval numbers, 9 approval numbers; as well as 42 special applications for clinical trials in accordance with new drug application procedures. For generic drugs, 251 clinical trial applications and 224 production applications have been approved. For imported drugs, 316 applications for clinical trials have been approved along with 93 applications for marketing.

In 2017, CFDA approved a total of 2,158 drug supplementary applications and filed 546 applications. The food and drug administrations of all provinces (autonomous regions and municipalities) of China approved a total of 4,251 drug supplementary applications and filed 12,264 records. In 2017, CFDA approved a total of 552 applications for production of packaging materials and containers in direct contact with drugs, 338 applications for registration renewal, and 62 supplementary applications.