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.
Permanent link to this Catalogue record:
publications.gc.ca/pub?id=9.882674&sl=0
| Department/Agency | Canada. Health Canada, issuing body. |
|---|---|
| Title | Guidance document : preparation of regulatory activities in the Electronic Common Technical Document (eCTD) format. |
| Variant title | Preparation of regulatory activities in the Electronic Common Technical Document (eCTD) format |
| Publication type | Monograph |
| Language | [English] |
| Other language editions | [French] |
| Format | Electronic |
| Electronic document | |
| 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. |
| Publishing information | [Ottawa] : Health Canada = Santé Canada, 2020. ©2020 |
| Description | 1 online resource (88 pages) : illustrations |
| ISBN | 9780660334400 |
| Catalogue number |
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| Departmental catalogue number | 190496 |
| Subject terms | Drugs -- Government policy -- Canada. Drugs -- Specifications -- Canada. |
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