conditional approval
- Guideline or reference source
- EMA Glossary of terms
- Definition
- The approval of a medicine on the basis of less complete clinical data than are normally required, because it answers an unmet medical need. To gain conditional approval, the available data must indicate that the medicine’s benefits outweigh its risks and the applicant should be in a position to provide the comprehensive clinical data in the future.
- Used For
- conditional marketing authorisation
- Broader Term
- approval
- Related Term
- specific obligation
Send comments to info@qdossier.com Please read disclaimer before using Qsauri.