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Drug Approval Controls Tightened
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China's top food and drug quality watchdog yesterday announced stricter rules for approving new medicines.

The move came a day after its former chief Zheng Xiaoyu, who headed the State Food and Drug Administration (SFDA) from 1998 to 2005, was executed after being found guilty of taking bribes to approve substandard and fake medicines blamed for at least 10 deaths.

Effective October 1, the regulation aims to make the drug registration and approval process transparent, and curb power abuse and corruption, Wu Zhen, deputy chief of the SFDA, told a news briefing:

A collective decision - instead of a single person or department as was the previous practice - has to be made by a special panel before the green light is given to a new drug.

Pharmaceutical producers and R&D institutes alike will easily access all information regarding approval procedures. "Transparency is the enemy of corruption. That's why we have introduced the new regulation," Wu said.

"Previously, pharmaceutical companies had to tap connections within the SFDA to find out how their application for new drugs was being handled and who was in charge of it," said a Beijing-based practitioner, who did not want to be named.

Local watchdogs will be authorized to conduct preliminary approval procedures to increase efficiency. This is a shift from the practice introduced by Zheng, who in 2003 withdrew all approval powers from local branches.

Companies found to have provided false information or samples will not be allowed to apply for up to three years.

The SFDA will make surprise spot checks on drug producers.

At the press conference, the drug watchdog said it is continuing its probe into methotrexate, a drug routinely prescribed to treat acute leukemia and rheumatoid arthritis, but had eliminated production errors as a cause of the problems.

The drug, made by Shanghai Hualian Pharmaceutical Co., was suspended from sale and use after adverse reactions were reported on July 6 in several juvenile leukemia patients in three hospitals in Guangxi Zhuang Autonomous Region and Shanghai.

Wu said "the team sent to reevaluate the drug has uncovered no problems with the raw materials used to make the drug or any violations of production procedures."

He added that investigators were shifting their attention to transportation, storage, and administration of the drug.

In a related development, officials yesterday ordered small, loosely-regulated food producers to clean up their act.

A notice posted by the General Administration of Quality Supervision, Inspection and Quarantine on its website said that hygiene requirements will be raised for food processors.

"By 2009, the number of small food processors will probably drop by 50 percent, and by 2012 no uncertified producer will remain in business," the notice said.

Rules ban the re-use of ingredients, and use of unapproved additives and substances.

China has more than 448,000 food producers, of which half have incomplete certification and one-third no certification at all, the notice said. Three in four employ fewer than 10 people.

Ministry of Commerce spokesman Wang Xinpei told a regular news conference that officials had noted the "doubts and comments" about Chinese food and drugs in the international media.

"The problems of several individual products should not be extended to the overall quality of Chinese exports," Wang said. "Chinese products are recognized and accepted by overseas distributors and consumers."

Meanwhile, SFDA Director Shao Mingli was quoted yesterday on the administration's website as saying that Beijing was capable of ensuring food safety during the 2008 Summer Games.

China will serve as a "model for food safety" and for future Olympic events, he said.

(China Daily, Xinhua News Agency July 12, 2007)

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