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Jan 18 2017

What’s New Health Canada? Jan 2017

By Amelie Rodrigue-Way, Ph.D., RAC (CAN), Associate Director, Regulatory Strategy, and Christine Straccini, B.Sc., Regulatory Associate; Cato Research Canada

 

What’s New in:

Therapeutic Products Directorate:

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/update-miseajour/index-eng.php

Biologics and Genetic Therapies Directorate:

http://www.hc-sc.gc.ca/dhp-mps/brgtherap/update-miseajour/index-eng.php

Medical Devices: http://www.hc-sc.gc.ca/dhp-mps/md-im/update-miseajour/index-eng.php

Natural and Non-prescription Health Products Directorate: http://www.hc-sc.gc.ca/dhp-mps/prodnatur/new-neuf-eng.php

 

 

Health Canada New Guidance Documents (Drugs and Biologics):

October – December 2016

 

Health Canada Guidance/Notice

Type

Date Posted
Updated – Guidance Document: Preparation of Regulatory Activities in the “Non-eCTD Electronic-Only” Format

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/ctd/gd_prep_non_ectd_ld-eng.php

Guidance

14 Dec 2016
Guidance Document: Information and Submission Requirements for Biosimilar Biologic Drugs

http://www.hc-sc.gc.ca/dhp-mps/brgtherap/applic-demande/guides/biosimilars-biosimilaires-eng.php

Guidance

02 Dec 2016
Patented Medicines (Notice of Compliance) Regulations

http://www.hc-sc.gc.ca/dhp-mps/alt_formats/pdf/prodpharma/applic-demande/guide-ld/patmedbrev/pmreg3_mbreg3-eng.pdf

Draft Guidance

27 Oct 2016
How to Pay Fees to Health Products and Food Branch (HPFB)

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/costs-couts/crpay_rcfrais_for-eng.php

Guidance

19 Oct 2016
Post-Notice of Compliance (NOC) Changes: Quality Document

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/postnoc_change_apresac/noc_pn_quality_ac_sa_qualite-eng.php

Guidance

14 Oct 2016
Consultation on the Health Canada Draft Guidance Document: Quality (Chemistry and Manufacturing) Guidance: New Drug Submissions (NDSs) and Abbreviated New Drug Submissions (ANDSs)

http://www.hc-sc.gc.ca/dhp-mps/consultation/drug-medic/qual-ndsands-draft-ebauche-pdnpadn-eng.php

http://www.hc-sc.gc.ca/dhp-mps/consultation/drug-medic/qual-adden-gd-draft-ebauche-ld-eng.php

http://www.hc-sc.gc.ca/dhp-mps/consultation/drug-medic/qual-gloss-term-gd-draft-ebauche-ld-eng.php

http://www.hc-sc.gc.ca/dhp-mps/consultation/drug-medic/cpidce-gd-draft-ebauche-ld-dcipec-eng.php

This consultation was open for comment until December 4, 2016

Draft Guidance

2016/08/31

05 Oct 2016

Updates from Health Canada (Drugs and Biologics)

Type of Update and Link Date Posted
Notice: Mandatory Requirements for using the Common Electronic Submissions Gateway (CESG) 28 Dec 2016
Notice: Final Release: Part I – Health Professional Information and Part II – Scientific Information of the Guidance Document – Product Monograph 09 Dec 2016
Fact Sheet: Biosimilars

 

07 Dec 2016
Register of Innovative drugs

 

02 Dec 2016
Notice – Validation rules for regulatory transactions submitted to Health Canada in the electronic Common Technical Document (eCTD) format 01 Dec 2016
Notice: Release of Draft (Step 2) International Council for Harmonisation (ICH) Guidance: E11(R1): Addendum: Clinical Investigation of Medicinal Products in the Pediatric Population

 

04 Nov 2016
Notice: Release of the revised Post-Notice of Compliance (NOC) Changes – Quality Guidance

 

03 Nov 2016
Notice – Post-Notice of Compliance (NOC) Changes: Notices of Change (Level III) Form

 

03 Nov 2016
Product Monograph Brand Safety Updates

 

19 Oct 2016