Guidance document : quality (chemistry and manufacturing) guidance : new drug submissions (NDSs) and abbreviated new drug submissions (ANDSs).: H164-266/2018E-PDF

Permanent link to this Catalogue record:
publications.gc.ca/pub?id=9.867966&sl=0

Publication information
Department/Agency Canada. Health Canada.
Canada. Health Products and Food Branch.
Title Guidance document : quality (chemistry and manufacturing) guidance : new drug submissions (NDSs) and abbreviated new drug submissions (ANDSs).
Variant title Quality (chemistry and manufacturing) guidance : new drug submissions (NDSs) and abbreviated new drug submissions (ANDSs)
Publication type Monograph
Language [English]
Other language editions [French]
Format Electronic
Electronic document
Note(s) Issued also in French under title: Ligne directrice : qualité (chimie et fabrication) : présentations de drogue nouvelle (PDN) et présentations abrégées de drogue nouvelle (PADN).
Cover title.
"Health Products and Food Branch."
Includes addendum (questions and answers).
Issued also in HTML format.
Publishing information [Ottawa] : Health Canada = Santé Canada, [2017]
©2017.
Description 1 online resource (vi, 85 pages)
Catalogue number
  • H164-266/2018E-PDF
Subject terms Drugs
Health policy
Request alternate formats
To request an alternate format of a publication, complete the Government of Canada Publications email form. Use the form’s “question or comment” field to specify the requested publication.
Report a problem or mistake on this page
Date modified: