Addendum – Quality (chemistry and manufacturing) Guidance: Questions and Answers

From Health Canada


The purpose of the guidance document is to outline the Quality technical requirements and to assist submission sponsors in preparing the New Drug Submission or Abbreviated New Drug Submission to ensure an effective and efficient assessment process. It can also be used as guidance on the requirements for related drug submissions [for example (e.g.), Supplemental New Drug Submissions (SNDSs), Supplemental Abbreviated New Drug Submissions (SANDSs), Post-Notice of Compliance (NOC) Changes].

In this guide

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Download PDF (254 KB, 10 pages)

Details and history


October 30, 2017


July 1, 2018

Part of topic(s):

Chemical Entity Products/Quality

For assistance

Contact us by mail:

Bureau of Pharmaceutical Sciences (BPS)
Therapeutic Products Directorate
Health Products and Food Branch
Address Locator: 0201D
Health Canada
Ottawa, Ontario
K1A 0K9

By E-mail:
By Telephone: 613-946-6829
By Fax: 613-941-0571

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