What are the EU Regulations on Pediatric Medicines?
The EU has specific regulations for pediatric medicines to ensure that children have access to safe and effective treatments. The Paediatric Regulation (Regulation (EC) No 1901/2006) mandates that pharmaceutical companies must conduct pediatric clinical trials for new medicines, unless a waiver is granted. This regulation aims to improve the availability of medicines that are specifically designed for children and to ensure that existing medicines are appropriately tested and labeled for pediatric use.
