watchdog to strengthen drug trial inspections
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[December 17, 2015]
SHANGHAI (Reuters) - China's drug
regulator said on Thursday it will strengthen oversight of clinical
trials of new drugs, where it said regulation was falling short despite
a recent push to improve the quality of local drugs and compete better
with international rivals.
The China Food and Drug Administration has rejected dozens of drug
applications over the past few months due to false or incomplete
trial data. A further 82 firms withdrew applications earlier this
China, the world's second-biggest drugs market behind the United
States, is pushing an ambitious program of healthcare reforms to
improve its home-made medicines and reduce reliance on generic and
more innovative drugs from overseas.
The drug regulator said in a statement on Thursday that while some
regions had made progress in cracking down on poor drug trial data,
many regions were still falling behind.
"The inspection work in some regions is not being taken seriously
enough and the quality of inspection is too low," the regulator
said, adding it had recently done spot checks on clinical trial
bodies and in many cases found false and incomplete data.
China's crackdown on poor quality drugs follows a call in July for
manufacturers to carry out their own internal investigations into
trial data, which had already led to a number of voluntary recalls.
Global drugmakers in China are facing a tough challenge as local
firms get increasingly competitive and as the central government
looks to rein in drug prices to help curtail a wider medical bill
expected to hit $1.3 trillion by around 2020.
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The top 10 Chinese drugmakers have seen sales grow around 12 percent
this year, according to data from IMS Consulting, twice the rate of
international rivals whose sales have slowed since a bribery scandal
at GlaxoSmithKline two years ago.
(Reporting by Adam Jourdan; Editing by Christopher Cushing)
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