China to Approve Much-Needed Foreign Drugs up to Two Years Faster
Ma Xiaohua
DATE:  Jun 25 2018
/ SOURCE:  Yicai
China to Approve Much-Needed Foreign Drugs up to Two Years Faster China to Approve Much-Needed Foreign Drugs up to Two Years Faster

(Yicai Global) June 25 -- China's government is easing the permission process for some selected foreign drug imports, which may fill the gaps in the domestic medical market.

China State Food and Drug Administration has created a list of 339 new drugs that could treat a host of diseases which currently do not have effective cures in China, the CFDA told in a briefing, adding that the list includes medicine for life-threatening conditions such as AIDS and cancer.

The regulator will approve rare-disease medicines within three months and grants permits for other clinically needed drugs within six months, said Jiao Hong, director of the CFDA, adding that this is expected to shorten application processes from one to two years.

Pharmaceutical approvals in China can take up to seven years longer than in the US, Europe, and Japan. From 2007-2014, some 48 percent of foreign medical firms waited for 1-5 years to get approvals in China, while 35 percent of them were held back for 6-10 years, and some 17 percent had to wait for even longer, over 10 years.

While accelerating the review process for new foreign drugs, the regulator will step up supervision regarding currently circulating drugs which have been confirmed to have serious side effects, Jiao said, adding that the CFDA has taken measures to stop imports of some 19 drugs to ensure the safety of domestic consumers.

Editor: Emmi Laine

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Keywords:   R&D,New Products,Medicine,Drug Approval Process,Government Regulator,Foreign Drugs,Imports,Trade