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Pediatric drug approval getting faster each year

By Wang Xiaoyu | chinadaily.com.cn | Updated: 2022-06-01 15:36
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China's top drug regulator has speeded up approval for pediatric medications in recent years, the National Medical Products Administration said on Tuesday.

The administration has granted pediatric drugs priority when it comes to reviews, and has set up green channels and designated personnel to supervise approval procedures to reduce review times as much as possible.

Last year, 47 pediatric drugs or medications previously not eligible for use were granted market approval, among them inhalants, rotavirus vaccines and traditional Chinese medicines. 

"The number of newly approved drugs was far higher than the previous year," the administration said, adding that the number of applications and approvals for pediatric drugs has been trending upward in recent years.

Between January and April, the administration completed 30 approval procedures for 21 pediatric drugs, eight of which had qualified for priority review. 

"The completed workload for pediatric drug evaluation increased by 90.91 percent on the same period last year," the administration said.

In the meantime, it has been importing new pediatric drugs in urgent demand.

Some of the newly approved products include an injection for spinal muscular atrophy and another for treating Fabry disease, a genetic condition that causes a buildup of fats in the bloodstream.

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