Approval sped up for pediatric drugs

China's top drug regulator has sped up approval for pediatric medications in recent years, the National Medical Products Administration said on Tuesday.

The administration has granted pediatric urgently-needed 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.

The development of pediatric drugs is even more contentious and time-consuming than that of drugs for adults due to obstacles and uncertainties associated with rolling out clinical trials or devising dosages.

Last year, 47 pediatric drugs or medications previously not eligible for children's 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 over 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 infusion for spinal muscular atrophy and another for treating Fabry disease, a rare genetic condition that causes a buildup of fats in the bloodstream.

On May 21, a 10-year-old girl in Chongqing received Replagal, the drug for treating Fabry disease, at the Children's Hospital of Chongqing Medical University.

The drug was selected for a list of medications qualified for expedited review and approval in 2018 and granted market approval in China in August, 2020. In October last year, the medication was added onto the national drug reimbursement list.

Wang Mo, head of the nephrology department at the hospital, said during an interview with People's Daily that each round of treatment required two injections, which would have cost 6,000 yuan ($896).

With reimbursement, the girl's family only needed to cover less than 3,000 yuan, she said.