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The 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).
A complete register of all scientific guidance published online by the European Medicines Agency is available.
Table of contents
- Quality guidelines
- Non-clinical guidelines
- Clinical efficacy and safety guidelines
- Multidisciplinary (paediatrics)
Quality guidelines
| Document(s) | Language | Status | First published | Last updated | Effective Date |
|---|---|---|---|---|---|
| Guideline on excipients in the dossier for application for marketing authorisation of a medicinal product | (English only) | adopted | 19/06/2007 | 01/01/2008 | |
| Volume 3b guidelines medicinal products for human use Safety, environment and information Excipients in the label and package leaflet of medicinal products for human use | (English only) | adopted | 01/07/2003 |
Non-clinical guidelines
| Document(s) | Language | Status | First published | Last updated | Effective Date |
|---|---|---|---|---|---|
| Guideline on the need for non-clinical testing in juvenile animals of pharmaceuticals for paediatric indications | (English only) | adopted | 24/01/2008 | 01/08/2008 |
Clinical efficacy and safety guidelines
| Document(s) | Language | Status | First published | Last updated | Effective Date |
|---|---|---|---|---|---|
| ICH: E 11: Clinical investigation of medicinal products in the paediatric population - Step 5 | (English only) | adopted | 01/01/2001 | 01/01/2001 | |
| Guideline on the role of pharmacokinetics in the development of medicinal products in the paediatric population | (English only) | adopted | 28/06/2006 | 01/01/2007 | |
| Guideline on clinical trials in small populations | (English only) | adopted | 27/07/2006 | 01/02/2007 | |
| Guideline on conduct of pharmacovigilance for medicines used by the paediatric population | (English only) | adopted | 25/01/2007 | 26/01/2007 | |
| Note for guidance on evaluation of anticancer medicinal products on man: Addendum on paediatric oncology | (English only) | adopted | 24/07/2003 | 01/01/2004 |
Multidisciplinary (paediatrics)
Related links
- 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)