The State Council released a new guideline
on October 8th, 2017 which allows drugs developed in other countries
to be available for use on the Chinese mainland more quickly.
According to the guideline on reforming
approval procedures, authorities in China will now accept data collected from
clinical trials conducted outside the mainland for applications to register
drugs and medical equipment.
Under existing rules, foreign firms are
required to provide data from six to 10 months of trials conducted in China,
but only after they have completed multiple phases of clinical trials in their
countries of origin. According to CFDA official Wu Zhen, this has delayed the
availability of some major drugs on the Chinese market. Of 433 drugs approved
for sale in developed countries between 2001 and 2016, only 30 percent are
available on the Chinese mainland. Over the past 10 years, patients on the
mainland have had to wait five to seven years longer for some major new drugs
than patients in Europe and the United States. The CFDA will make more detailed
regulations to better carry out the guideline, Wu said.
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