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China FDA issues directive to accept overseas clinical trial data for drugs

The China Food and Drug Administration will start accepting clinical data from overseas trials for drugs with immediate effect, it said in a release on its website Oct. 10.

The directive comes two days after China's State Council proposed reforms to speed up drug approvals and encourage innovation, suggestions that largely mirrored what the CFDA said in a May release.

The regulator first proposed eliminating a local trial requirement for new drugs in March. Under the new policy, drugmakers would be able to file new drug applications based on data from international multicenter trials, if they included China as one of the study sites.

Earlier, manufacturers that wished to market their products in China had to run separate local trials for additional data, even if they had carried out multicenter trials. This regulatory requirement often meant that new drugs in developed markets could not be launched in China until several years later.

But with the new policy in place, multinational drug manufacturers will be able to market their products in China simultaneously with other markets.

In addition, the CFDA has decided to scrap a requirement needing imported drugs to be approved in other countries before it can be approved in China or used in local clinical trials.

CFDA director Bi Jingquan said the reforms were aimed at speeding up drug approvals to meet public needs, improve drug safety and quality, and encourage innovation.

"Over the past decade or so, the country has made great efforts to improve manufacturing business standards, but the level in the pharmaceutical industry is still low compared to international standards," Bi said in a release posted on the CFDA website.

Innovation from domestic manufacturers remained low, and there was lack of imported drugs in China, he said.

From 2001 to 2016, China approved 133 new drugs while the U.S. approved about 433, Bi said. New drugs launched in the U.S. and Europe typically face a five- to seven-year lag before they can be launched in China, and this delay often leads patients to seek healthcare services overseas or buy drugs online, Bi said.