Regulatory Blog

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May 142 min read

Health Canada: Guidance on Preparation of Regulatory Activities in Non-eCTD Format & Filing submissions electronically

Health Canada recently (13 May 2024) updated its guidance "Preparation of Regulatory Activities in Non-eCTD Format" (electronic Common...

Nov 30, 20231 min read

Health Canada: Guidance on Validation rules for Regulatory Transactions in the eCTD Format

Health Canada recently published an updated guidance on "Validation rules for regulatory transactions provided to Health Canada in the...

Jul 30, 20231 min read

Canada HC Guidance: Nitrosamine Impurities in Medications

Last Friday (28 July, 2023) Health Canada published an updated "Guidance on Nitrosamine Impurities in Medications" that details about...

Jul 2, 20231 min read

Health Canada: Guidance on Master Files Procedures & Administrative Requirements

Health Canada recently (26 June, 2023) published an updated guidance on "Guidance on Procedures and Administrative Requirements for...

Feb 1, 20231 min read

Health Canada Guidance: Conduct and Analysis of Comparative Bioavailability Studies

Recently (30 January 2023) Health Canada updated their guidance document on "Conduct and Analysis of Comparative Bioavailability...

Sep 30, 20221 min read

Canada Guidance: Regulatory Enrolment Process (REP)

Yesterday (29-September 2022) Health Canada updated their guidance on Regulatory Enrolment Process (REP). Health Canada's Regulatory...

Sep 14, 20221 min read

Health Canada: Udated Register of Innovative Drugs

The Register of Innovative Drugs is maintained pursuant to subsection C.08.004.1(9) of the Food and Drug Regulations of Health Canada and...

Aug 30, 20221 min read

Health Canada Recommendations: ICH Q3D(R2) Guideline for Elemental Impurities

Yesterday (29-August-2022) Health Canada notified that Recommendations on the Implementation of the Revised ICH Q3D(R2) Harmonized...

Aug 4, 20221 min read

Health Canada: Guidance Document Management of Drug Submissions and Applications & Post-DIN Changes

Health Canada on August 2, 2022, revised the Guidance Document entitled: The Management of Drug Submissions and Applications (MDSA). This...