System Analysis of Pediatric Regulation in the European Union
OBJECTIVE To analyze the key contents of paediatric regulation in the European Union(EU)and identify the characteristics of the European regulation for paediatric medicines.METHODS A literature review was conducted to analyze the EU paediatric regulation,relevant guidance documents and published literatures.RESULTS The EU has established the paediatric medicines committee,which is specifically responsible for issues related to the regulation of paediatric medicines.Moreover,the EU has systematically designed the regulation around four aspects including obligations,rewards and incentives,other initiatives for paediatric medicines research and information and transparency measures.CONCLUSION The EU attaches great importance to building a professional team for the regulation of paediatric medicines,focusing on both mandatory and incentives,and emphasizing the concepts of the whole life cycle of medicines and dynamic adjustments,which provide a comprehensive guarantee for promoting the development and availability of paediatric medicines.It deserves to be studied and learned from.