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Companies warned to tread carefully with new drug applications
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08:10, July 12, 2007

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China has amended drug registration and administration measures, bringing in stiffer punishments for companies that cheat in applications for new medicines, the drug watchdog said on Wednesday.

Applicants who submit false drug information and samples for approval in clinical tests will be rejected, said Wu Zhen, deputy director of the State Food and Drug Administration (SFDA).

"Their other applications will also be refused for 12 months from the date of the rejection," Wu said.

Companies who wrongly gain approvals will see their clinical test permits revoked and will be fined 10,000 to 30,000 yuan (1,316 to 3,947 U.S. dollars). Subsequent applications will be refused for a period of three years, Wu said.

Those applying to production or import of medicines with bogus materials and samples will get similar punishments, he said, adding that a five-year ban on applications will be meted out if applicants are deemed to have gained manufacture or import approvals by cheating.

The punishments and fines are stiffer than in the original measures, he said.

"The new measures aim to improve applicants' sense of responsibility and intensify verification work in the drug application process, as part of the country's efforts to standardize the drug market," he said.

The amended measures will take effect on Oct. 1, 2007.

Wu also said a credit system will be established for all medicine manufacturers.

"Under the system, a company will be blacklisted if it cheats in applications for clinical tests or medicine production. Punishment will be designed to hinder the sales of the company's other products on the market," he said.

Source: Xinhua



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