Success of European Commission’s paediatric regulation is established

1 This statement is referenced by an article written by a consultant to pharmaceutical companies, and former employee of several of them. 2 His opinion is not shared by most other stakeholders, including the European Commission. 3 During its first five years the regulation has resulted in an increased percentage of clinical trials in children and neonates, 221 changes of paediatric relevance in the product information of authorised medicines, 89 additions of dosage information for children, 77 other modifications to report on new study data, 34% of medicines being authorised by the European Medicines Agency with a paediatric indication from the beginning, 72 new paediatric indications for already authorised products, and 26 new paediatric specific formulations. 4 Therefore the success of the regulation is established and not questionable.