Current legislation, both in the US and EU, requires drug developers to further consider the potential therapeutic benefit of their drugs in children. Prior to the implementation of the respective paediatric legislation the children were often excluded from the clinical development as drugs were developed and approved in the adult population only. Thus, the paediatric patient population were deprived from the benefits of drugs approved in adults only, similar to the patients with rare diseases

Specific paediatric plans must be submitted to both the FDA and EMA. This is, however, required at different stages of clinical development in the adult population. In the US, a paediatric study plan (PSP) or waiver needs to be submitted to the FDA prior to a submission of an NDA (new drug application) for the adult population. While EMA will not validate a submission for MAA without a PIP (Paediatric Investigation Plan). Thus, not submitting a PIP in time can delay the application for marketing authorisation in the adult population and thus it´s authorisation in Europe.