China will introduce
stricter measures in its approval of new medicines to cure its
"disorderly" drug industry, according to the country's top food and
drug administrator.
Director of the State Food and Drug Administration
(SFDA) Shao Mingli was speaking at a national conference on drug
administration that closed in Beijing on Thursday.
"In order to curb rampant and irregular registration
of new drugs, the country's drug watchdogs will not only check the
qualification of producers but also inspect research labs and
analyze clinical experiment records," the China Securities Journal
quoted an unidentified source with the SFDA as saying.
The source said a thorough examination will also cover
the drugs already on sale.
Many Chinese pharmaceutical companies are known to
have registered new drugs by copying existing products as new drugs
can be sold at much higher prices than old ones.
The government is revising a law to narrow the
definition of new drugs and control the registration of imitation
products, the SFDA source told the newspaper.
In each of the past few years, the SFDA handled more
than 10,000 applications for registering new drugs, compared with
merely 148 accepted by the United States in 2004.
Meanwhile, only 212 of the new drugs approved by the
SFDA in the 2003-2005 period have their own intellectual property
rights.
"Ninety-six percent of China's chemical drugs are
imitations as our drug companies can't afford the high cost of
developing new drugs," said Zou Xinjin, an analyst with the China
Securities Research Co., Ltd..
Chinese pharmaceutical enterprises invest less than
three percent of their revenues in research and development,
compared with eight to ten percent in developed
countries.
"Most of the 5,000 drug companies in China have very
few famous brands, while redundant production has led to oversupply
and reduced competitiveness," said Liu Yanming, an analyst with the
China Galaxy Securities Co., Ltd.
Statistics show the combined output of the country's
top ten drug companies only equaled 12 percent of Pfizer
Pharmaceuticals Limited, the world's largest drug
producer.
Analysts say a stricter registration system for new
drugs is expected to boost those medicinal companies with
advantages in research and development and fuel mergers and
acquisitions in the industry.
(Xinhua News Agency January 21, 2007)
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