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China tightens approval of new medicines
www.chinanews.cn 2007-07-12 09:41:36
(Source: China Daily)
July 12 - The country'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.
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.
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