China continues to fine-tune drug, food safety procedures

Print 11 January 2016
Matthew Driskill / FiercePharmaAsia

The government of China continues to refine its legal powers to deal with drug safety issues, according to a release from the country's Supreme Court that says investigations will be streamlined to identify administrative cases that potentially involve major criminal breaches.

The new measures are designed to "facilitate coordination between administrative and judicial organs in handling food and drug safety cases," according to a report from the Shanghai Daily.

The China Food and Drug Administration (CFDA) and the Ministry of Public Security, the Supreme People's Court, the Supreme People's Procuratorate and the executive office of the food safety commission under the State Council, China's cabinet, said the measures will "streamline" standards and procedures and will include the possibility of suspected drug cases being transferred from administrative bodies such as the CFDA to police.

The measures also call on food and drug safety officials, public security organs and judicial authorities at all levels "to establish a collaboration mechanism in sharing and publishing information of the cases," the Shanghai Daily reported.

Officials also want to develop an online system to track cases of suspected safety crimes.

The officials involved in the new package of measures said previously drug safety was compromised because of "ambiguous standards" or "undefined responsibilities of different authorities."

These latest moves are an attempt by Chinese officials to bring trust to the "Made in China" label because most Chinese prefer foreign-made drugs which they believe are higher quality. Several Chinese and Indian companies in recent months have been slammed by regulatory authorities in the United States and Europe over lapses in good manufacturing practices and outright fraud in many cases where test results were falsified.

In December, the CFDA announced it was implementing tougher rules for clinical trials and in August it imposed new deadlines on drugmakers to submit audited data on trials, warning that "irregularities" in trial data could result in unannounced inspections and penalties.

The head of the CFDA earlier this month warned that problems with clinical trials and other industry problems were a "cancer" on China's pharmaceutical industry and said the industry must be "reborn" to succeed.

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