Health & Beauty

According to the State Food and Drug Administration, the bureau is striving to solve the clinical dilemma of "children's medicine depends on breaking, and the dosage depends on guessing", actively encourages the research and development of children's medicines, and accelerates the review and listing of children's medicines. The State Food and Drug Administration stated that it will give priority to the review and approval of pediatric drugs that have clinical value and are urgently needed by patients, open a green channel for pediatric drugs, proactively serve R&D companies, and arrange project managers to specialize in monitoring and reviewing the progress of tasks to promote pediatric drugs. Speed up the review and listing. Comprehensively promote the work of children's drug use. Actively provide services in the communication, acceptance, review and other links of enterprises, improve the efficiency of variety processing, and minimize the review time.

In the whole year of 2021, a total of 47 special medicines for children and medicines with increased children's application were approved for marketing, and 14 were included in the priority review and approval sequence, and the number of approvals was much higher than in previous years. In the first four months of this year, the Drug Evaluation Center of the State Food and Drug Administration completed 30 technical review tasks for children's medicines, a total of 21 varieties, including 8 priority review and approval varieties. Compared with the same period in 2021, the number of technical review tasks for children's medication has increased by 90.91%. The State Food and Drug Administration actively encourages and promotes the accelerated import of original research pediatric drugs that are urgently needed in clinical practice: Focusing on improving the access of Chinese children to the use of original research imported drugs for which there is no effective treatment in my country, and narrowing the accessibility gap of pediatric drugs at home and abroad, foreign-funded enterprises are encouraged to actively Report and adopt centralized, fast and orderly processing methods.

In recent years, my country has accelerated the approval of 16 children's medicines, including Nosinagen Sodium Injection for 5q Spinal Muscular Atrophy and Agalsidase Alpha Injection Concentrate for Fabry Disease.