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New Guideline to Speeds Up Foreign Drug Approval

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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