Scientific guidelines: paediatrics
Table of contents
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.
Guidelines
- Clinical evaluation of medicinal products used in weight control - addendum on weight control in children - Scientific guideline
- Clinical investigation of medicinal products for the treatment of Duchenne and Becker muscular dystrophy - Scientific guideline
- Clinical trials in small populations - Scientific guideline
- Superseded - Conduct of pharmacovigilance for medicines used by the paediatric population - Scientific guideline
- Evaluation of anticancer medicinal products in man - addendum on paediatric oncology - Scientific guideline
- ICH E11(R1) step 5 guideline on clinical investigation of medicinal products in the pediatric population - Scientific guideline
- Investigation of medicinal products in the term and preterm neonate - Scientific guideline
- Paediatric addendum on the CHMP guideline on clinical investigation of medicinal products for the treatment of acute heart failure - Scientific guideline
- Paediatric addendum to the guideline on clinical investigation on medicinal products in the treatment of hypertension - Scientific guideline
- Paediatric addendum to the guideline on clinical investigation of medicinal products in the treatment of lipid disorders - Scientific guideline
- Paediatric addendum to the guideline on clinical investigation of medicinal products for the treatment of pulmonary arterial hypertension - Scientific guideline
- Role of pharmacokinetics in the development of medicinal products in the paediatric population - Scientific guideline
Reflection papers
- Extrapolation of efficacy and safety in paediatric medicine development - Scientific guideline
- Formulations of choice for the paediatric population - Scientific guideline
- Ethanol content in herbal medicinal products and traditional herbal medicinal products used in children - Scientific guideline
- Necessity of initiatives to stimulate the conduct of clinical studies with herbal medicinal products in the paediatric population - Scientific guideline
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 - Scientific guideline
- Impact of brain immaturity when investigating medicinal products intended for neonatal use - Scientific guideline
- Impact of liver immaturity when investigating medicinal products intended for neonatal use - Scientific guideline
- Impact of lung and heart immaturity when investigating medicinal products intended for neonatal use - Scientific guideline
- Impact of renal immaturity when investigating medicinal products intended for paediatric use - Scientific guideline
- Involvement of children and young people at the Paediatric Committee - Scientific guideline
Project reports
Collaborative approach
Response