Guidance document : preparation of regulatory activities in the Electronic Common Technical Document (eCTD) format. : H164-293/2019E-PDF
"This guidance document defines the electronic Common Technical Document (eCTD) electronic-only format process requirements and provides guidance on the structure and content of information to be included in regulatory activities filed to Health Canada. This guidance document is to be used in the preparation and filing of drug regulatory activities to Health Canada in the eCTD electronic-only format as established by the International Council on Harmonization (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use"--Introduction, page 8.
Lien permanent pour cette publication :
publications.gc.ca/pub?id=9.882674&sl=1
| Ministère/Organisme | Canada. Health Canada, issuing body. |
|---|---|
| Titre | Guidance document : preparation of regulatory activities in the Electronic Common Technical Document (eCTD) format. |
| Variante du titre | Preparation of regulatory activities in the Electronic Common Technical Document (eCTD) format |
| Type de publication | Monographie |
| Langue | [Anglais] |
| Autres langues publiées | [Français] |
| Format | Électronique |
| Document électronique | |
| Note(s) | Cover title. "Effective date: March 13, 2020." Issued also in French under title: Ligne directrice : préparation des activités de réglementation en format Electronic Common Technical Document (eCTD). Includes bibliographical references. |
| Information sur la publication | [Ottawa] : Health Canada = Santé Canada, 2020. ©2020 |
| Description | 1 online resource (88 pages) : illustrations |
| ISBN | 9780660334400 |
| Numéro de catalogue |
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| Numéro de catalogue du ministère | 190496 |
| Descripteurs | Drugs -- Government policy -- Canada. Drugs -- Specifications -- Canada. |