Paediatric Medicines - Regulatory Drivers, Restraints, Opportunities and Challenges.

摘要: Abstract The investment in the pharmaceutical development of medicines for paediatric use represents a minority when compared to that one made adult population. Which reasons lie behind this status quo? policies have been implemented reverse such asymmetry? Is there room new regulatory initiatives? creation regulations establishing obligation conduct trials was deemed necessary as means producing products proven quality, safety and efficacy and, addition, set forth financial incentives industry reduce delay. first initiatives were carried out by Food Drug Administration (FDA) at end 20th century. Later on, European Medicines Agency (EMA) issued Paediatric Regulation, which has boosted closer collaboration between both agencies. Along with legislation, dosage forms, more adapted population emerged, increasing availability age-appropriate formulations. However, case-by-case analysis is required ensure best therapeutic option specific child. This review aims discussing from perspective, comparing adopted EMA FDA, following an overview drivers, restraints, opportunities challenges.