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Evidence of Good Manufacturing Practices (GMP) for drug submissions. The goal of this revision is to better align the drug …
This guidance document is specific to the "tamper-resistance" feature of controlled-release opioid products. It is intended for the pre-market review …
This guidance document applies to sponsors intending to make changes to new drugs that have received a NOC pursuant to …
After a new drug as defined in section C.08.001 of the Food and Drug Regulations has been granted a Notice …
This guidance document applies to sponsors intending to make changes to new drugs that have received a NOC pursuant to …
A post-NOC change is any change that is made to a new drug that has received a NOC pursuant to …
This guidance document applies to sponsors intending to make changes to new drugs that have received a NOC pursuant to …
Health Canada is publishing this document to be transparent about the principles and factors that it considers when deciding whether …
This guidance aims to articulate Health Canada's expectations and generate a level of consistency regarding the interpretation of the Priority …
The purpose of this guidance document is to assist sponsors in developing product monographs with acceptable format and content. Health …