In the first May of 2023, 34 children's drugs received more approvals than in the same period last year

From January to May of 2023, 34 drugs for children have been approved for marketing, more than the same period last year, covering rare diseases, frequently-occurring and common diseases in children, and acute and critical diseases in children. This is the information obtained from a symposium on promoting drug development and scientific supervision for children in 2023 held in Beijing on June 1.

Children are the future of a country and the hope of a nation, and their health is an important guarantee for sustainable economic and social development. In recent years, the State Food and Drug Administration has been working hard to review and approve children's drugs, and has taken a series of effective measures to encourage the research and development of children's drugs and accelerate the review and approval of children's drugs, with remarkable results. The situation of Chinese children's drug use has been improving year by year, and children's health needs have been met constantly.

It is reported that the scientific supervision system of children's drug use has been continuously improved. Since 2019, 17 guiding principles related to children's drug use have been formulated and released, providing technical guidance for the R&D registration of enterprises. Both the number of children's drug applications and the quantity of drugs obtained showed an obvious upward trend. From 2019 to 2022, 158 children's drugs were approved for marketing, and another 34 children's drugs were approved since the beginning of this year. Including risprolan oral solution powder for spinal muscular atrophy (SMA) in patients aged 2 months and older, subelingual drops for artemisia annua/artemisia annua pollen allergen in patients aged 4 years and older with allergic rhinitis (or conjunctivitis), and a large number of clinically urgent children's drugs are on the market. The problems of less dosage form and less specification suitable for children have also been further alleviated.