000 02072nam  2200361zi 4500
0019.882674
003CaOODSP
00520221107170347
006m     o  d f      
007cr cn|||||||||
008191205t20202020onca    ob   f000 0 eng d
020 |a9780660334400
040 |aCaOODSP|beng|erda|cCaOODSP
043 |an-cn---
0861 |aH164-293/2019E-PDF
24500|aGuidance document : |bpreparation of regulatory activities in the Electronic Common Technical Document (eCTD) format.
24610|aPreparation of regulatory activities in the Electronic Common Technical Document (eCTD) format
264 1|a[Ottawa] : |bHealth Canada = Santé Canada, |c2020.
264 4|c©2020
300 |a1 online resource (88 pages) : |billustrations
336 |atext|btxt|2rdacontent
337 |acomputer|bc|2rdamedia
338 |aonline resource|bcr|2rdacarrier
500 |aCover title.
500 |a"Effective date: March 13, 2020."
500 |aIssued also in French under title: Ligne directrice : préparation des activités de réglementation en format Electronic Common Technical Document (eCTD).
504 |aIncludes bibliographical references.
520 |a"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.
650 0|aDrugs|xGovernment policy|zCanada.
650 0|aDrugs|xSpecifications|zCanada.
7101 |aCanada. |bHealth Canada, |eissuing body.
77508|tLigne directrice : |w(CaOODSP)9.882675
85640|qPDF|s3.98 MB|uhttps://publications.gc.ca/collections/collection_2021/sc-hc/H164-293-2019-eng.pdf