00000nam 2200000zi 4500 9.882674 CaOODSP 20221107170347 m o d f cr cn||||||||| 191205t20202020onca ob f000 0 eng d 9780660334400 CaOODSP eng rda CaOODSP n-cn--- H164-293/2019E-PDF Guidance document : preparation of regulatory activities in the Electronic Common Technical Document (eCTD) format. Preparation of regulatory activities in the Electronic Common Technical Document (eCTD) format [Ottawa] : Health Canada = Santé Canada, 2020. ©2020 1 online resource (88 pages) : illustrations text txt rdacontent computer c rdamedia online resource cr rdacarrier 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. "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. Drugs Government policy Canada. Drugs Specifications Canada. Canada. Health Canada, issuing body. Ligne directrice : (CaOODSP)9.882675 PDF 3.98 MB https://publications.gc.ca/collections/collection_2021/sc-hc/H164-293-2019-eng.pdf 190496