The Beijing News reported on Tuesday that China's drug watchdog will consider taking measures to address the country's lack of children's drugs such as granting children's drug producers easier market access or exclusive market shares.
Dong Jiangping, an official with the State Food and Drug Administration (SFDA), made the remarks at a symposium on children's drug safety held by the SFDA on Monday.
AdvertisementChildren's drugs are lacking in China, and children are often administered small doses of drugs made for adults. Drug usage instructions do not specify doses for children, but suggest using "a lesser dose" or to "follow a doctor's instructions."
The adverse effects of drugs threaten children. Official statistics show that children under 14 accounted for 11.5 percent of the total cases of adverse drug effects last year, and they also comprised 10.3 percent of the total cases of severe adverse effects.
The SFDA announced at the symposium that it is considering a slew of measures to improve the quality of children's drugs.
These measures include tightening the approval of children's drugs, not only evaluating their safety, efficacy and the steadiness of quality, but also whether the amount of drug administered is appropriate and whether supplementary ingredients in drugs are safe for children.
The SFDA will also provide incentives for pharmaceutical companies to engage in drug research and trials such as granting them exclusive market shares.
This is a common practice in some developed countries, Dong said. In order to guarantee profits to pharmaceutical companies engaged in clinical studies on children's drugs, they are given a window of six months to one year during which no other companies are allowed to develop the same drugs.
Dong said China would consider adopting the same practice.
Drug companies are usually reluctant to invest in clinical studies for children's drugs, because it is a lengthy and costly process as parents are not willing to allow their children to be test subjects.
Song Hulin, a law professor with Nankai University, was quoted as saying that the lack of children's drugs is a universal problem.
Moreover, Song suggested a state fund be established to subsidize relevant research and provide tax rebates to children's drug producers.
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