paediatric investigation plan
- Guideline or reference source
- EMA Glossary of terms
- Definition
- A development plan aimed at ensuring that the necessary data are obtained to support the authorisation of a medicine for children, through studies in children. All applications for marketing authorisation for new medicines have to include the results of studies as described in an agreed paediatric investigation plan, unless the medicine is exempt because of a deferral or waiver.
- Abbreviation for
- PIP
- Related Term
- deferral, paedicatric
- paediatric committee
- product-specific waiver
Send comments to info@qdossier.com Please read disclaimer before using Qsauri.