ectd application
- Guideline or reference source
- EUeCTD4 EU Module 1 implementation guide draft for testing
- TIGES Harmonised guidance for ectd submissions in the eu
- Definition
- A collection of electronic documents compiled by a pharmaceutical company or its agent in compliance with European legislation and guidelines in order to seek a marketing authorisation or any amendments thereof. An eCTD application may comprise a number of sequences. In the EU an eCTD application may comprise several dosage forms and strengths, all under one invented product name. Some review tools describe such a collection as a dossier.
- Narrower Term
- sequence
- Related Term
- ectd baseline
- ectd identifier
- electronic common technical document
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