Paediatric indications

The EU regulation on medicinal products for paediatric use entered into force on January 26, 2007. The regulation aims to advance the development of high quality and ethically researched medicinal products for children without subjecting children to unnecessary trials.

Are you planning a study?

Feel free to request our
planner for clinical trials
or our
planner for non-interventional (observational) studies.

Benefit from the expertise of our Paediatric Medicines Group (PMG) and from our recommendations on how to practically implement the specific requirements of clinical trials and non-interventional (observational) studies in premature infants, newborns, infants, toddlers, children and adolescents. Save your own resources and take advantage of our services:

  • Paediatric Investigation Plan (PIP)
  • Waiver
  • Deferral
  • Paediatric-Use Marketing Authorisation (PUMA)

Please find further information about our complete clinical research service in the section Service.

Useful links related to pediatrics:

  European Commission / Medicines for Children

  European Medicines Agency / Paediatric Medicine Development

  EUDRACT

  BfArM / Medicines for Children
  (German Federal Institute for Drugs and Medical Devices)

  PEI / Medicines for Children
  (Paul-Ehrlich-Institut)