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News, Policy

China Issues New Rules To Spur Innovative In New Drug And Medical Devices, Accepts Overseas Clinical Data

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The Chinese government announced a new policy directive to further encourage innovation in new drug development and medical device yesterday, making significant changes to existing policies to spur an already thriving healthcare sector in the country.

In a major policy move that attracted positive feedback from industry participants, the General Office of the Central Committee of the Communist Party of China and the State Council jointly released the new policy, named the Review and Approval System Reform and Support Drug and Medical Device Innovation, last week.

“All my healthcare groups are discussing this historic policy revolution. I am deeply encouraged by the leadership’s determination to push for market reform and innovation under such heavy pressure. This new policy is truly a great correction of many of the industry’s lasting mistakes,” an anonymous healthcare veteran said.

In 2015, the market size of innovative drug industry worldwide was US$600 billion, but China only accounts for 6.2% of the global market, according to local reports. For medical devices industry, the market size in China is expected to reach RMB450 billion (US$68 billion) by the end of this year, while that number for worldwide is estimated at US$398 billion, according to Visiongain and China Medical Pharmaceutical Material Association.

The most significant change in the new policy is that data obtained from overseas multi-center clinical trials can be used directly for the innovative drug and medical device application process in China. As a result, China’s innovative drug approval, usually lasting as long as eight years partly due to the requirement for additional clinical trial conducted in the country for all overseas innovative drugs, could be significantly shortened.

In March, the China Food and Drug Administration (CFDA) already released a directive with an objective to shorten the gap between innovative drug approval at home and overseas. At that time, the CFDA removed the requirement that all innovative drugs need to complete the second or third clinical trials, in order to conduct clinical trial in international multi-centers in China.

In addition, the policy released yesterday said the approval for new drugs and medical devices that are urgently needed will be accelerated. New drugs that has proved early- and mid-stage effectiveness for severe diseases that has currently no effective cure will also have its approval period shortened, the new policy said.

Other measures include that the government will also support the development of drugs and medical devices for rare diseases in China, and put an emphasis on the protection and innovation of traditional Chinese medicine, which allows classic formulas of traditional Chinese medicine to get approval from a simplified standard.

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