Overview:
On March 1, the first “Live conference on Industry Guidelines for Pediatric Drugs”, co-sponsored by the Center for Drug Evaluation of the National Medical Products Administration (hereinafter referred to as Center for Drug Evaluation) and the China Association for Drug Administration, was successfully held online.
Introduction
Pointed out the shortage of drugs for children has seriously affected the healthy development of children in China. To meet the urgent clinical needs and the urgent demands of pediatric usage for new drugs and good drugs, CDE has comprehensively increased its efforts and taken many measures since last year to address the needs of children’s drug use.
Measures Taken during Conference:
- Special leading group
- Working group on pediatric drug use
- Construction of Pediatric Medication Guidelines
- Disclosure of pediatric medication information
- Establish a long-term mechanism to steadily advance steadily by stages and projects.
Recent Achievements made by the conference
| 64 technical review tasks for pediatric drugs and supplementary pediatric indications have been completed in 2021. |
| 24 priority reviews |
| 12 guidelines for pediatric use were issued to provide important technical support and evaluation basis for R & D and review. |
| They have actively carried out the standardized and supplementary work of pediatric medication information in two batches of 8 marketed package inserts. |
The next stage will also focus on strengthening the deep integration of production, education, and research, and continuously improving the safety and accessibility of drugs for children.
Questions? GRP team is ready to help you!
References
For the link, click here (Only available in Chinese).
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