34 medicines for children have been approved and listed in the first 5 months of 2023, exceeding that of the same period last year
The approval of medication for children has gained an accelerating pace, with 34 medicine for children approved for marketing in January-May 2023, more than the same period last year, covering grounds in rare diseases, common diseases, acute and critical illnesses in children.
Children are the future of the country and the hope of the nation, and children's health is an important guarantee for sustainable economic and social development. In recent years, the State Drug Administration has continued to do a good job of reviewing and approving children's medicines with all its heart and strength, and has taken a series of powerful initiatives to encourage research and development and innovation of children's medicines, and accelerate the review and approval of children's medicines, which has achieved remarkable results. The situation of children's medication in China has been improving year by year, and children's health needs have been continuously met.
It is reported that China's scientific regulatory system for children's medicines has been improving, and 17 guiding principles related to children's medicines have been formulated and released since 2019, providing technical guidance for enterprises' R&D and registration. The number of children's drug declarations and approvals have shown a significant upward trend, with a total of 158 children's drugs approved for marketing from 2019 to 2022, and 34 more children's drugs have been approved so far this year, including Risperdal Oral Solution with Bulk for the treatment of spinal muscular atrophy (SMA) in patients 2 months of age and older, Risperdal Oral Solution with Bulk in patients 4 years of age and older with allergic rhinitis caused by pollen allergy to Artemisia annua/Artemisia absinthium (or Artemisia annua pollen allergen sublingual drops for patients with allergic rhinitis caused by Artemisia annua/ Artemisia annua pollen (or with conjunctivitis) aged 4 years and above, and a large number of urgently needed children's drugs have been listed on the market.
Source: China Food and Drug Network