Scientific guidelines: Paediatrics

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This page lists the European Medicines Agency's scientific guidelines, reflection papers and concept papers relevant to the development of medicines for children.

These documents are produced by the Paediatric Committee (PDCO) and the Committee for Medicinal Products for Human Use (CHMP) and are aimed at helping applicants prepare marketing-authorisation applications for human medicines.

A complete register of all scientific guidelines published online by the Agency is available.

If you have comments on a document which is open for consultation, use the Form for submission of comments on scientific guidelines.

Quality

TopicDocumentsReference numberPublication dateEffective dateRemarks
Excipients in the dossier for application for marketing authorisation of a medicinal productAdopted guidelineEMEA/CHMP/QWP/396951/2006June 2007January 2008 
Pharmaceutical development of medicines for paediatric useAdopted guidelineEMA/CHMP/QWP/805880/2012 Rev. 2July 201315 February 2014 

Non-clinical

TopicDocumentsReference numberPublication dateEffective dateRemarks
Need for non-clinical testing in juvenile animals of pharmaceuticals for paediatric indicationsAdopted guidelineEMEA/CHMP/SWP/169215/2005January 2008August 2008 

Clinical efficacy and safety

TopicDocumentsReference numberPublication dateEffective dateRemarks
Extrapolation of efficacy and safety in paediatric medicine developmentReflection paperEMA/199678/2016April 2016  
Extrapolation of efficacy and safety in medicine development

Overview of comments

Concept paper

Draft concept paper

EMA/129698/2012April 2013September 2012 
Investigation of medicinal products in the term and preterm neonate

Overview of comments

Adopted guideline

Draft guideline

EMEA/536810/08July 2009January 2010 
Clinical trials in small populationsAdopted guidelineCHMP/EWP/83561/2005July 2006February 2007 
Conduct of pharmacovigilance for medicines used by the paediatric population

Overview of comments

Adopted guideline

Draft guideline

Concept paper

EMEA/CHMP/235910/05June 2006January 2007 
Role of pharmacokinetics in the development of medicinal products in the paediatric populationAdopted guidelineEMEA/CHMP/EWP/147013/2004June 2006January 2007 
Evaluation of anticancer medicinal products on man: Addendum on paediatric oncologyNote for guidanceEMEA/CPMP/EWP/569/02July 2003January 2004 
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use: E 11: Clinical investigation of medicinal products in the paediatric population - Step 5Note for guidanceCPMP/ICH/2711/99January 2001January 2001 

Multidisciplinary

TopicDocumentsReference numberPublication dateEffective dateRemarks
Gaucher disease: A strategic collaborative approach from European Medicines Agency and Food and Drug AdministrationDraft collaborative approachEMA/44410/2014Released for consultation May 2014 Deadline for comments 31 August 2014
Committee for Medicinal Products for Human Use Safety Working Party’s response to the Paediatric Committee regarding the use of PEGylated drug products in the paediatric populationResponseEMA/CHMP/SWP/647258/2012November 2012  
Involvement of children and young people at the Paediatric CommitteeConcept paperEMA/PDCO/388684/2012September 2012 Deadline for comments 19 November 2012
Formulations of choice for the paediatric population

Overview of comments

Reflection paper

Note of explanation

EMEA/CHMP/PEG/194810/2005July 2006September 2006 
Impact of brain immaturity when investigating medicinal products intended for neonatal useConcept paperEMEA/181377/06Released for consultation June 2006 Deadline for comments 31 December 2006
Impact of lung and heart immaturity when investigating medicinal products intended for neonatal useConcept paperEMEA/CHMP/PEG/114218/06Released for consultation March 2006 Deadline for comments 30 September 2006
Impact of liver immaturity when investigating medicinal products intended for neonatal useConcept paperEMEA/CHMP/PEG/194605/05Released for consultation July 2005 Deadline for comments 31 January 2006
Impact of renal immaturity when investigating medicinal products intended for paediatric useConcept paperCPMP/PEG/35132/03December 2004December 2004 

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