China introduces new pediatric drug regulations
Minhua Chu ·09/29/2021

Chinese drug regulators are making it clear that pediatric drug development is at the top of its agenda with a slew of new regulations.

In 2020, the NMPA approved 26 drugs specifically for pediatric use or with added indications for children, amounting to a 36.8% increase year-on-year.

Two more new regulations came in early September. The NMPA’s Center for Drug Evaluation (CDE) issued two technical guidelines on pediatric drugs to regulate the clinical trials of new modified chemical drugs for children and the content about indications for children on drug labels.

These come after another two guidelines issued last year that were directed at the pharmacological development of chemical drugs for children as well as real-world studies that support the review and development of pediatric drugs.

This focus on pediatric drugs has achieved several results. Regulators have improved the system for reviewing and evaluating pediatric drugs, some of which were approved through priority review. The information on pediatric drugs has been revised and added to labels.

In addition, a document on the management of essential drugs, which is currently soliciting comments, proposed a first-ever special classification of children's drugs. Pediatric drugs are placed in a separate category equal to chemical and biological drugs. They get priority distribution to primary medical institutions as well.

Accelerating approvals

For a long time, China lacked drugs specifically designated for children. A survey conducted by Beijing Children's Hospital from 2011–2019 showed that at least 45% of drug inserts lacked information about appropriate dosage for children.

To meet clinical needs, the CDE is accelerating approvals for pediatric drugs.

Since 2016, three batches of pediatric drug lists were released to encourage companies to develop drugs in dosage forms and specifications for children. In 2020, the CDE settled a separate review channel for pediatric drugs and granted priority review for them.

According to the NMPA’s media arm China Medical News, the NMPA approved 26 drugs specifically for pediatric use or with added indications for children in 2020, amounting to a 36.8% increase year-on-year.

The development and approval of pediatric drugs continue to increase this year. Currently, there 14 pediatric drug have been approved for the market. Dozens of drugs, added indications, or dosages for children are under review. Among them, 22 have been granted priority review status.

Introducing real-world studies

On the R&D level, a new policy was also introduced to accelerate drug development.

Although a number of supportive regulations have been announced, long development time, high costs and low profits still deter companies from developing pediatric drugs.

The clinical studies of pediatric drugs are very difficult, especially when it comes to recruiting participants and ensuring safety,” Ni Xin, president of Beijing Children's Hospital, told China Medical News.

To solve this problem, the CDE released technical guidelines on real-world evidence to support drug developers in submitting drug applications based on data from real-world studies.

The mechanism for real-world data to be used for drug registration will benefit pediatric drugs the most, Ni said.

The CDE also uses data from children's hospitals to standardize and increase useful information on drug labels. Using real-world study data expedites the process.

For the next step, the CDE and the National Children Medical Center will integrate resources to continue to promote the development and regulatory review of children's drugs, solve the problems in how children's drugs are administered, and help to improve children's health,” said Kong Fanpu, the director of the CDE.

Standardizing labels

But developing pediatric drugs will still take some time. In the meantime, the CDE has established a program to standardize labels for pediatric drugs .

The shortage of drugs designated for children has been an issue at hospitals like Beijing Children's Hospital, Wang Xiaoling, director of the Department of Pharmacy told China Medical News. He added that his hospital has to cut the dosages of drugs intended for adults to meet children's needs.

“A survey conducted by the Department of Pharmacy at Beijing Children’s Hospital showed that in 2018, a total of 79 oral tablets used in the inpatient pharmacy had to be split, some for premature babies even had to be reduced to 1/25 or even 1/50 of the original dose,” Wang said.

In June 2018, the CDE began standardizing and adding information to labels for pediatric drugs.

The CDE has reviewed and screened two batches of drugs with labels requiring revision. The first batch has been completed, and drug labels with increased indications and dosages for children were officially released on May 31 this year.

Editing by Elise Mak and Justin Fischer

Keywords: new pediatric drug regulations NMPA new modified chemical drugs for children real-world studies
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