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SFDA to keep a public blacklist of pharma manufacturing offenders

By Natalie Morrison , 20-Aug-2012
Last updated on 20-Aug-2012 at 13:15 GMT

The SFDA will name and shame companies and individuals responsible for violations of drug and medical device laws in a public blacklist.

Under the plan the Chinese regulator will publish the list on a Government website as a deterrent for would-be wrongdoers. Major drug cases in action will also appear on the list.

The agency said it believes the move will encourage foreign manufacturers to be more vigilant when assessing suppliers also urged Government lawmakers to keep a closer eye on those blacklisted and recommended suspensions of up to 10 years for the worst offenders.

“Due to serious violations of the drug, medical device management laws, regulations and rules, administrative penalties and information about the production and operation of its responsible personnel will be published on a Government website for social supervision and implementation of key regulators.

“The drug safety 'blacklist' column should increase the frequency of inspection and random testing, quality management and other measures ordered to regularly report to the implementation of key regulations.”

The news follows a series of current good manufacturing practice (cGMP) scandals in the country, including the production of adulterated heparin in 2008  and the closure of 10 capsule factories this year after inspectors found chromium-tainted gelatin .

"The recent capsule scandal exposed loopholes in supervision. The new regulation aims to fill in the blanks," SFDA director Yin Li told Xinhuanet.

The SFDA also said it hopes to establish a “credit system” as part of the move to encourage whistle-blowers to come forward and strengthen social supervision force to deter violations.”

Going national

In its announcement, the SFDA also hinted that it would regulate drug production in China on a more national level, moving away from the current model in which a lot of enforcement powers are devolved to the provinces.

The committee responsible for the changes said: "Regulations require food and drug supervision departments at or above the provincial level."

However, the localities still hold the power when implementing the blacklist’s management strategy.

“Provinces food and drug regulatory authorities with local conditions will formulate the rules for the implementation of the blacklist management of drug safety,” the statement said.

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