What are the main measures of the Paediatric Regulation?
• Obligation of paediatric research (PIP – Paediatric investigation Plan) for every new drug developed for adults and having a potential use for children. • Creation of an inventory of specific needs for paediatric medicinal products. • Creation of a Paediatric Committee (PDCO) including patient representatives at the European Medicines Agency (EMEA). • Six-months extension of the patent for the paediatric formula of existing still under-protection adult medicine. • Two-years extension of market exclusivity for orphan drugs for children (12 years in total instead of the 10 years for adult orphan drugs). • Financial support via the EU Framework Programmes for research on old (off-patent) drugs to study and develop paediatric use. • Implementation of a process to avoid unnecessary clinical studies on children. • Specific label products studied in children and authorised: the Paediatric Use Marketing Authorization (PUMA).
