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The draft guidance document clarifies the requirements for eligible drug submissions and applications under the administrative pathway. These submissions and …
Revisions to change #2 (Appendix 1) have been made to the Guidance Document: Post-Notice of Compliance (NOC) Changes: Quality. The …
A final version of the Guidance Document: Use of Certificates of Suitability as supporting information in Drug Submissions is now …
Release of the Final Guidance Document: Drug Submissions Relying on Third-Party Data (Literature and Market Experience)
Health Canada is pleased to announce the release of the final revised Guidance Document: Notice of Compliance with Conditions (NOC/c).
…The updated screening criteria for Abbreviated New Drug Submissions (ANDS) and their supplements (SANDS) will help assess the completeness of …
Health Canada is revising the Guidance Document entitled: The Management of Drug Submissions and Applications (MDSA).
The Guidance Document: Fees for the Review of Drug Submissions and Applications has been updated. The Document Change Log has …
The attached policy has been developed to provide for the filing of Supplemental New Drug Submissions, Supplemental Abbreviated New Drug …
This document is intended to provide Industry with guidance for the preparation of drug submissions for Biotechnological/ Biological Products. It …