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China issues new drug rules

16th July 2007

China's drug regulator has announced new rules aimed at tightening up controls over the country's pharmaceuticals and herbal medicines industry in the wake of the execution of a former top regulator.

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The State Food and Drug Administration (SFDA) announced the regulations a day after the execution of Zhen Xiaoyu, former SFDA chief who was convicted of taking bribes and approving unsafe products, by the Beijing No.1 Intermediate People's Court.

The new rules, which replace a set of regulations dated 2005, have stepped up requirements for drug safety before a new drug can be approved, with the bar set higher on both quality and supervision of the approval process.

Wu Zhen, deputy head of the SFDA, told a news conference the regulations would require applicants to ensure the safety of their candidate drug. They also stipulate that drug evaluators will make surprise spot inspections, and take samples to check for safety and consistency of drugs.

Evaluators will also ensure that samples provided in the application are consistent with the final product, Wu told reporters.

Greater transparency is being introduced in the hope that making evaluators' names public will help prevent graft. Any evaluators who have an interest in the product applying for approval would be barred from the approval process under the new rules.

Wu said that new regulations were also aimed at encouraging innovation in China's pharmaceutical sector — currently dominated by generics — by prioritising new drug applications.

The definition of what constitutes a new drug has been tightened, ruling out generic drugs in a different dosage or in new packaging which used to be sold at a premium because they were regarded as new.

The sheer volume of applications testifies to the scale of the problem faced by the Chinese government in regulating this industry.

In 2005, Beijing handled 11,086 drug applications, including 1,113 applications for new drugs. The United States Federal Drug Administration (FDA) approved only 81 new drugs during the same period.

However, the new rules still define 'new drugs' as drugs that have not been sold in China before, rather than totally new chemicals or biological-based medicines.

Meanwhile, Cao Wenzhuang, Zheng Xiaoyu's former secretary and former head of SFDA's drug registration department, was sentenced to death with two years stay on 6 July, also for drug approval-related corruptions.

 

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