5. Special cases in marketing authorisations: Paediatric medicines
1. Paediatric medicines
1.1. The Regulation – obligations and measures
- establishment of the EMA’s expert Paediatric Committee (PDCO) responsible for coordinating the EMA's work on medicines for children and to provide opinions on the development of paediatric medicines;
- a mandatory Paediatric Investigation Plan (PIP) (Artl. 7 and 8 of the Paediatric Regulation):
- binding research and development plan that details quality, non-clinical and clinical steps necessary for obtaining a paediatric indication, agreed with the Paediatric Committee (PDCO) at end of phase I studies in adults.
- Applications will be regarded as valid only if they include, in addition to the particulars and documents required by previous pharmaceutical legislation, the results of all studies performed and details of all information collected in compliance with an agreed Paediatric Investigation Plan (PIP) unless exempt because of a waiver.
- a system of PIP waivers for specific medicines or classes of medicines
- a system of PIP deferrals allows delayed development of the paediatric medicine
- the Paediatric Use Marketing Authorisation (PUMA): a new type of MA, a voluntary procedure, applicable to any off-patent medicine developed for exclusive use in the paediatric population.