China continues to find problems in drug production

Officials at the China Food and Drug Administration (CFDA) said this week they were continuing to crack down on substandard drugs being produced by the country's pharmaceutical companies, with the latest tests snaring Sichuan Changzheng Pharmaceutical and 13 other manufacturers.

The regulators said 16 batches of isoniazid tablets failed tests along with a host of other medications used in children's cough medicines and nasal drops and in drugs used to prevent miscarriages, among others.

CFDA officials said in a release that they were continuing to investigate the companies involved in several provinces including Tianjin, Hebei, Shanxi, Liaoning, Jilin, Jiangxi, Hubei, Chongqing and others.

Chinese regulatory officials have made good manufacturing practices a priority as the country looks to move up the value chain in drug production from mainly being a bulk drug producer into the finished drug market.

China is said to be eager to demonstrate its tough regulatory oversight, but the country balks at some foreign oversight and has kept the U.S. Food and Drug Administration from beefing up its inspection staff in the country.

- here's the statement from the CFDA (in Chinese)
- here's the second statement from the CFDA (in Chinese)


Using AI and RWD to Uncover Rare Disease Insights, Accelerate Commercialization and Improve Patient Outcomes

Wednesday, March 24 | 2pm ET / 11am PT

Learn how transformed real world data into real world insights to assist Audentes in their development of AT132 for the treatment of XLMTM. The session reviews how IPM.ia and Audentes collaborated to uncover the XLMTM patient population.