Worldwide paediatric regulations

Abstract The ‘Worldwide Paediatric Regulations’ chapter focuses on the key features of the US and EU Paediatric Regulations with the objective to provide sufficient insight to understand their objectives, obligations and procedures, and similarities and differences; both regulations are permanent and provide the main paediatric regulatory framework in the world. The recent Swiss regulation is briefly presented, and references are also made to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). Comprehensive information regarding the requirements of regulatory documentation can be found on the websites of the US Food and Drug Administration, FDA ( www.fda.gov ); the European Medicines Agency, EMA ( www.ema.europa.eu ); the ICH ( www.ich.org ); and the Swiss Agency for Therapeutic Products, Swissmedic ( https://www.swissmedic.ch ).