RESUMO
BACKGROUND: At present the EU-regulation on medicinal products for paediatric use is in the final legislation phase. The Regulation will bring essential changes to the policy of research with minors, to funding and to regulations of drug development in Europe. METHOD: The article analyses contents of the regulation and possible effects on research with and treatment of mentally ill minors. RESULTS: The regulation seems to be a chance to improve pharmacological treatment for children and bring similar research conditions to Europe as they already exist in the US. Some terms of the regulation must be considered as critical due to vague definitions and ambiguously defined policies in some articles. The designated expert committee will be a powerful institution, but it remains to be seen whether this committee will act in the intended way. It is an existing and real danger that European child and adolescent psychiatry will be neglected by the new regulation, if there is no participation of scientists of this discipline in committees. The regulation makes it necessary for child and adolescent psychiatry to strengthen research in clinical trials and developmental psychopharmacology to get benefits from new legislation and improve health care for mentally ill minors.