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Health Canada: Validation Rules for Regulatory Transactions in eCTD and Non-eCTD Formats
Health Canada has released detailed guidances addressing the validation rules for regulatory transactions submitted in two formats: "...
Sharan Murugan
Jan 263 min read
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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...
Sharan Murugan
May 14, 20242 min read
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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...
Sharan Murugan
Nov 30, 20231 min read
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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...
Sharan Murugan
Jul 30, 20231 min read
31 views
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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...
Sharan Murugan
Jul 2, 20231 min read
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Health Canada Guidance: Preparation of Regulatory Activities in Non-eCTD Format
Health Canada recently (09 June, 2023) published an updated guidance on "Preparation of Regulatory Activities in Non-eCTD Format" that...
Sharan Murugan
Jun 17, 20231 min read
175 views
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Health Canada: Guidance on Nitrosamine Impurities in Medications
Health Canada last week published an updated "Guidance on Nitrosamine Impurities in Medications" that details about on Evaluating and...
Sharan Murugan
Apr 23, 20231 min read
51 views
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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...
Sharan Murugan
Feb 1, 20231 min read
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Canada Guidance: Regulatory Enrolment Process (REP)
Yesterday (29-September 2022) Health Canada updated their guidance on Regulatory Enrolment Process (REP). Health Canada's Regulatory...
Sharan Murugan
Sep 30, 20221 min read
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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...
Sharan Murugan
Sep 14, 20221 min read
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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...
Sharan Murugan
Aug 30, 20221 min read
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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...
Sharan Murugan
Aug 4, 20221 min read
249 views
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