Scientific guidelines: paediatrics
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This page includes the European Medicines Agency's scientific guidelines that are specifically relevant to the development of medicines for children.
These documents help applicants prepare paediatric investigation plans and other development programmes in children, supporting authorisation in children. They are produced through a collaboration of several Committees and Working Parties of EMA, in particular by the Paediatric Committee (PDCO) and the Committee for Medicinal Products for Human Use (CHMP).
Information of paediatric relevance may also be included in general or disease-specific guidelines, not listed here. For a complete list of these documents, see Scientific guidelines.
For a complete list of scientific guidelines currently open for consultation, see Public consultations.
Clinical efficacy and safety
Guidelines
- Clinical evaluation of medicinal products used in weight control - addendum on weight control in children
- Clinical investigation of medicinal products for the treatment of Duchenne and Becker muscular dystrophy
- Clinical trials in small populations
- Conduct of pharmacovigilance for medicines used by the paediatric population
- Evaluation of anticancer medicinal products in man - addendum on paediatric oncology
- ICH E11(R1) step 5 guideline on clinical investigation of medicinal products in the pediatric population
- Investigation of medicinal products in the term and preterm neonate
- Paediatric addendum on the CHMP guideline on clinical investigation of medicinal products for the treatment of acute heart failure
- Paediatric addendum to the guideline on clinical investigation on medicinal products in the treatment of hypertension
- Paediatric addendum to the guideline on clinical investigation of medicinal products in the treatment of lipid disorders
- Paediatric addendum to the guideline on clinical investigation of medicinal products for the treatment of pulmonary arterial hypertension
- Role of pharmacokinetics in the development of medicinal products in the paediatric population
Reflection papers
- Extrapolation of efficacy and safety in paediatric medicine development
- Formulations of choice for the paediatric population
- Ethanol content in herbal medicinal products and traditional herbal medicinal products used in children
- Necessity of initiatives to stimulate the conduct of clinical studies with herbal medicinal products in the paediatric population
Concept papers
- Addendum to the guideline on the evaluation of medicinal products indicated for treatment of bacterial infections to address paediatric-specific clinical data requirements
- Impact of brain immaturity when investigating medicinal products intended for neonatal use
- Impact of liver immaturity when investigating medicinal products intended for neonatal use
- Impact of lung and heart immaturity when investigating medicinal products intended for neonatal use
- Impact of renal immaturity when investigating medicinal products intended for paediatric use
- Involvement of children and young people at the Paediatric Committee
Project reports