On March 28^th, China’s National Medical Products Administration (NMPA) published a list of 30 new drugs that are “urgently needed” in China.  To encourage the international pharmaceutical companies to submit their new drug applications to NMPA, the agency will  waive any clinical trials requirement, to the extent the drug sponsors can submit data demonstrating there are no racial or ethnic differences that would affect the efficacy.  This marks the second time the China drug regulator directly calling on the industry to provide better patience access to new treatments that are currently available in U.S., EU, or Japan, but unavailable in China.  NMPA uses the following three criteria in selecting these “urgently needed” new drugs: 1) orphan drugs; 2) for life-threatening diseases and currently no effective treatment; 3) for life-threatening diseases and have substantial clinical advantage.  Significantly, under the NMPA review guideline published in October 2018 for the “urgently needed” new drugs, the target review time for these new drugs is only six months (three months if they are also orphan drugs).  It is reported that since August 2018, when NMPA published the first list of 48 “urgently needed” new drugs, 11 listed drugs have been approved.    

 The public can submit comments to the NMPA within 5 working days (by April 4^th), if they disagree with NMPA listing any of the 30 new drugs as “urgently needed” in China.  Query on what basis could the public object to the listing of a new drug as “urgently needed.”  We will continue to monitor the status of any regulatory changes and reforms by NMPA.

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