Draft Guidance for Industry: Quality Guidance: Applications for Drug Identification Numbers (DINAs) for Pharmaceuticals

This document is intended to provide guidance with respect to the Quality (Chemistry and Manufacturing) portion of Applications for Drug Identification Numbers (DINAs) for chemical entities. The purpose of the guidance document is to outline the Quality technical requirements and to assist sponsors in preparing the DINAs to ensure an effective and efficient review process.

Data and Resources

Additional Info

Field	Value
Source
Version
Author
Author Email
Maintainer
Maintainer Email
Data Level
Agreement Required
Purpose Constraints
Redistribution Allowed
AI Training Allowed
Data Steward
Title (French)	Ébauche ligne directrice à l'intention de l'industrie : Ligne directrice : Section Qualité des demande d'identification numérique de drogues (DDIN) de produits pharmaceutiques
Update Frequency	as_needed
Geographic Scope	[]
Criticality Level	[]
Sensitivity Level	unrestricted
Language
Contact Person
Contact Email
Data Dictionary
Open Canada Date Published	2020-11-18 00:00:00
Open Canada Date Modified
Open Canada Subject	["health_and_safety"]
Open Canada Keywords	{"fr": ["projet de guide pour l'industrie", "guide de qualité", "demandes de DIN", "DINA pour les produits pharmaceutiques"], "en": ["draft-guidance for industry", "quality guidance", "applications for DIN", "DINAs for pharmaceuticals"]}
Open Canada Collection	publication
Principal Organization
Reference Data
Official Source