European Medicines Agency - Human Medicines - Medicines for children - Scientific guidance

Paediatric-related information
Scientific guidance
The EMEA's Committee for Medicinal Products for Human Use (CHMP) draws up scientific guidelines aimed at helping applicants prepare marketing-authorisation applications for medicinal products for human use.

Below are the titles of scientific guidelines, reflection papers and concept papers relevant to the development of medicines for children (the list is non-exhaustive).

The guidelines themselves are located in the central repository 'Scientific guidelines for human medicinal products', where they are categorised under the same headings as shown here.

Quality guidelines
Excipients in the dossier for application for marketing authorisation of a medicinal product (EMEA/CHMP/QWP/396951/2006)
Excipients in the label and package leaflet of medicinal products for human use (3bc7a)
Non-clinical guidelines
Need for non-clinical testing in juvenile animals on human pharmaceuticals for paediatric indications (EMEA/CHMP/SWP/169215/2005)
Clinical efficacy and safety guidelines
ICH E11 Clinical investigation of medicinal products in the paediatric population (CPMP/ICH/2711/99)
Role of pharmacokinetics in the development of medicinal products in the paediatric population (EMEA/CHMP/EWP/147013/2004/Corr)
Clinical trials in small populations (CHMP/EWP/83561/2005)
Guideline on conduct of pharmacovigilance for medicines used by the paediatric population (EMEA/CHMP/PhVWP/235910/2005)
Addendum on Paediatric Oncology (CPMP/EWP/569/02) to the Guideline on the Evaluation of Anticancer Medicinal Products in Man (CPMP/EWP/205/95 Rev. 3)
Multidisciplinary (paediatrics)
Guideline on the Investigation of Medicinal Products in the Term and Preterm Neonates
Overview of the comments received on the guideline can be found here

Ethical considerations for clinical trials on medicinal products conducted with the paediatric population (Recommendations of the ad hoc group for the development of implementing guidelines for Directive 2001/20/EC relating to good clinical practice in the conduct of clinical trials on medicinal products for human use)
Reflection paper: Formulations of choice for the paediatric population (EMEA/CHMP/PEG/194810/2005)
Overview of comments received on draft reflection paper: Formulations of choice for the paediatric population (EMEA/359361/2006)
Note of explanation to accompany publication of reflection paper on formulations of choice for the paediatric population (EMEA/196218/2005)
Concept paper on the impact of brain immaturity when investigating medicinal products intended for neonatal use (EMEA/181377/2006)
Concept paper on the impact of lung and heart immaturity when investigating medicinal products intended for neonatal use (EMEA/CHMP/114218/2006)
Concept paper on the impact of liver immaturity when investigating medicinal products intended for neonatal use (EMEA/CHMP/PEG/194605/2005)
Discussion paper on the impact of renal immaturity when investigating medicinal products intended for paediatric use (CPMP/PEG/35132/03)
A proposal for a revision of the European Commission Summary of Product Characteristics Guideline has been released for consultation.
This revision (changes highlighted) mainly aims to reflect new requirements in relation to the paediatric regulation. Please refer to: http://www.emea.europa.eu/htms/human/genguidance/regaffairdraft.htm

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European Medicines Agency - Human Medicines - Medicines for children - Scientific guidance