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China approves market entry of 21 medicines for children
Published on: 2024-06-03
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China's National Medical Products Administration on Saturday announced that it has approved the market entry of 21 medicines for children this year, with about a third being prioritized for accelerated entry.
 

In recent years, the administration has stepped up its policy support for the research and development, approval and production of medicines for children, resulting in market entry approvals for an increasing number of drugs.
 

Statistics show that since 2019, the administration has approved 271 medicines for children.
 

It has pledged to implement greater preferential policies to facilitate the review and approval of medicines for children, and to intensify the protection of related intellectual property rights.
 

It has also pledged efforts to provide more technological guidance to R&D companies, ensuring special requirements such as safety and suitability for children are taken into full consideration in R&D processes.
 

数量明显提升 今年我国已有21个儿童用药获批上市

近年来,国家药监局积极鼓励儿童用药研发创新,儿童用药上市数量明显提升,进一步满足儿童患者临床急需。

2024年1—5月,已有21个儿童用药获批上市,涵盖了儿童罕见疾病、儿童多发病常见病、儿童危急重症等领域。其中,以儿童用药理由纳入优先审评审批程序得以加快上市的品种7个,罕见病用药7个。
2019年至今,共有271个儿童用药获批上市。

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