June 3, 2016 – Some children’s drugs that have been used in Hong Kong, Macao and Taiwan for years will be put on a fast track for importation, China’s top health authority said on Wednesday.
The National Health and Family Planning Commission released a list of 32 drugs to beexpedited. The medications are used to treat conditions ranging from cardiovascular diseaseto endocrine, blood and nervous system disorders.
Most of the drugs have passed clinical tests and been used for years in the three areas, butthey have not been available to doctors and patients on the Chinese mainland. Under currentrules, approval to import such drugs requires clinical test data collected on the mainland.
“Health authorities have always been concerned over ethical issues and fears of harmingchildren, especially babies,” said Zhang Yiran, marketing manager of the China office ofpharmaceutical giant Pfizer.
According to the commission, clinical studies in Hong Kong, Macao and Taiwan might beused to support approvals in the future, which means tests on people on the Chinesemainland may not be required.
About 2,200 babies are born in the country every hour. However, drugs for infants andchildren remain limited. Figures from the China Food and Drug Administration show that morethan 170,000 drugs were registered by 2015, but only about 3,000 of those were intendedspecifically for children.
Fewer options may pose higher risks for children, as many Chinese parents say they prefer togive them adult drugs in smaller doses to treat some mild diseases, such as colds or diarrhea.
“Dosages for children should be carefully measured. Otherwise, the drug can be renderedineffective or even harmful,” said Wang Fei, deputy director of the intensive-care unit atCapital Institute of Pediatrics.
Moreover, she said, drugs for children should have different forms and flavors that helpparents administer them more easily.
Beyond the concerns about clinical testing on the Chinese mainland, children’s drugs usuallycome with lower profit margins because of their relatively low dosages, Wang said.
“This new policy helps guide drug companies on new children’s drug research,” she said.