China eyes easier regulatory nod for imported pediatric medicines


China may allow the import of more drugs that are approved for children and are already sold in Hong Kong, Macao and Taiwan as signs grow that the abandonment of its one-child policy last year may spur tweaks to pediatric medicine policies.

China's National Health and Family Planning Commission (NHFPC), China Daily reports, said 32 drugs in doses appropriate for children were placed on a list for expedited imports that could possibly be allowed without local clinical trials.

China Daily, citing the NHFPC, said that clinical studies in Hong Kong, Macao and Taiwan might be used to support approvals, which would mark a notable exception in using clinical data from outside of the country.


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China has faced a persistent problem in supplying appropriate and clinically tested pediatric doses of many medicines, with doctors often prescribing modification of adult doses.

According to China Daily, the medicines under review for expedited imports cover cardiovascular, endocrine, blood and nervous system ailments and have been approved for years in the other jurisdictions.

China's one-child policy was lifted in late October, and analysts since then have pointed out that the country has a shortage of pediatric doctors and specialists as well as a lack of newer drugs in pediatric doses.

China Daily cited figures that showed that of the more than 170,000 drugs registered by China FDA by 2015, only about 3,000 had specific doses for children.

- here's the story from China Daily

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