China continues efforts to improve drug industry with tougher trial inspections

The China Food and Drug Administration (CFDA) is continuing its push to overhaul and improve the nation's healthcare system and said this week it will impose new rules on clinical trials of new drugs.

The push is designed to help domestic drugmakers compete with international rivals who have a leg up on their Chinese counterparts because of perceived and real quality problems at Chinese plants.

The CFDA has been on a recent campaign to improve the quality of drugs that are domestically produced and in recent months has rejected dozens of applications because of falsified test results, according to a report from Reuters, which added that an additional 82 applications were withdrawn in early December.

The regulator said this week that inspections "in some regions" were not being taken seriously and said the quality of inspections was also lacking, Reuters reported.

The U.S. Food and Drug Administration is also taking a sharper look at China because the country, along with India, is responsible for manufacturing the majority of bulk ingredients that go into finished products that are manufactured by other drugmakers. Disputes over visas for U.S. FDA inspectors have prevented the agency from exercising as much oversight as it wants.

As FiercePharmaAsia reported in August, the CFDA also gave drugmakers a deadline on submitting audited data from clinical trials and warned then that irregularities in the data could prompt unannounced inspections.

- here's the release from CFDA (in Chinese)
- here's the report from Reuters

EJ Lane contributed to this report.

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