What's New - Drug Products

Files added to the Web site are also posted here in the What's New section for three weeks. Once you have browsed through the entire site, all you need to do to keep current is make sure you visit this page more than once every three weeks.

Weekly Drug NOC updates

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Consult the Drug and Health Product Register regularly for Regulatory Decision Summaries for drugs.

Consult the Drug and Health Product Register regularly for Post-Authorization Activity Tables, which are added to Summary Basis of Decision documents for drugs.

2019

July

Statistical Report 2018 / 2019 - Patented Medicines (Notice of Compliance) Regulations, Data Protection (C.08.004.1 of the Food and Drug Regulations) and Certificates of Supplementary Protection [2019-07-16]
Qualifying Notice for Vitrakvi [2019-07-16]
Register of Innovation Drugs [2019-07-12]
Updated Register of Certificates of Supplementary Protection and Applications [2019-07-12]
Notice of Compliance (NOC) Data Extracts [2019-07-12]
Summary Basis of Decision (SBD) for BIOTHRAX [2019-07-10]
Summary Basis of Decision (SBD) for VONVENDI [2019-07-10]
Summary Basis of Decision (SBD) for DEMYLOCAN [2019-07-10]
Product Monograph Brand Safety Updates - June 2019 [2019-07-10]
Notice: Guidance on the Clinical Assessment of Abuse Liability for Drugs with Central Nervous System Activity [2019-07-08]
Notice: Prescription Drug List (PDL): Multiple Additions [2019-07-08]
Notice of Compliance (NOC) Data Extracts [2019-07-05]
Updated Register of Certificates of Supplementary Protection and Applications [2019-07-02]
Notice: Regulatory Enrolment Process (REP) Pilot for Veterinary Drugs [2019-07-02]
DPD Extracts [2019-07-02]

June

Register of Innovative Drugs [2019-06-28]
Notice of Compliance (NOC) Data Extracts [2019-06-28]
Notice: Revisions to the Guidance Document: Administrative Processing of Submissions and Applications Involving Human or Disinfectant Drugs [2019-06-28]
Drug and medical device highlights 2018: Helping you maintain and improve your health [2019-06-27]
Summary Basis of Decision (SBD) for BRINEURA [2019-06-27]
Summary Basis of Decision (SBD) for FULPHILA [2019-06-27]
Summary Basis of Decision (SBD) for LUTATHERA [2019-06-27]
Consultation on: Draft Guidance: Canadian Module 1 Technical Implementation Guide for the Electronic Common Technical Document (eCTD) v4.0 Format [2019-06-26]
Mandatory reporting requirements for hospitals [2019-06-26]
Submissions Under Review [2019-06-24]
Generic Submissions Under Review [2019-06-24]
Notice - Regulatory Enrolment Process (REP) implementation and expansion of the scope for the Common Electronic Submissions Gateway (CESG) [2019-06-20]
Notice of Compliance (NOC) Data Extracts [2019-06-21]
Notice - New regulatory activity types for filing to the Marketed Health Products Directorate (MHPD) [2019-06-21]
Updated Register of Certificates of Supplementary Protection and Applications [2019-06-20]
Updated List of Drugs for an Urgent Public Health Need [2019-06-19]
Register of Innovative Drugs [2019-06-17]
Notice of Compliance (NOC) Data Extracts [2019-06-17]
TPD/BGTD/NNHPD Quarterly Drug Submission Performance report for January - March 2019 & TPD/BGTD/NNHPD Annual Drug Submission Performance report for FY2018-2019 [2019-05-31]
Notice of Compliance (NOC) Data Extracts [2019-06-07]
Update Noticed: Introduction of the Regulatory Enrolment Process (REP) and the Use of the Common Electronic Submission Gateway (CESG) for Medical Devices [2019-06-07]
Updated List of Drugs for an Urgent Public Health Need [2019-06-05]
Updated Register of Certificates of Supplementary Protection and Applications [2019-06-04]
Updated Product Monograph Template - Schedule D and Schedule D Biosimilar Biologic Drug [2019-06-04]
DPD Extracts [2019-06-03]

May

Q3D(R1): Guideline for elemental Impurities [2019-05-31]
Notice of Compliance (NOC) Data Extracts [2019-05-31]
Updated List of Drugs for an Urgent Public Health Need [2019-05-28]
Notice of Compliance (NOC) Data Extracts [2019-05-24]
Summary Basis of Decision (SBD) for Crysvita [2019-05-24]
Summary Basis of Decision (SBD) for Folotyn [2019-05-24]
Summary Basis of Decision (SBD) for Unituxin[2019-05-24]
Summary Basis of Decision (SBD) for Veltassa [2019-05-24]
Scientific Advisory Committee on Oncology Therapies - Meeting announcement and Agenda for June 14, 2019 [2019-05-22]
Notice of Consultation on the Prescription Drug List: Vitamin D [2019-05-22]
Updated Register of Certificates of Supplementary Protection and Applications [2019-05-21]
Notice of Compliance (NOC) Data Extracts [2019-05-17]
Submissions Under Review [2019-05-16]
Generic Submissions Under Review [2019-05-15]
Final Report: Fees for Drugs and Medical Devices [2019-05-15]
Performance Standards for the Fees in Respect of Drugs and Medical Devices Order [2019-05-15]
Updated Guidance Document: Certificates of Supplementary Protection & Updated Certificate of Supplementary Protection (CSP) Application Form [2019-05-15]
Structured Product Monographies [2019-05-15]
Scientific/Expert Advisory Committee: Health Products for Women - Summary of Affiliations and Interests [2019-05-15]
Product Monograph Brand Safety Updates - April 2019 [2019-05-14]
Product Monograph Brand Safety Updates - May 2019 [2019-05-12]
Draft Guidance Document for Industry and Practitioners on the Special Access Program (SAP) for Drugs [2019-05-10]
Draft Guidance: Public or Canadian Armed Forces Health Emergencies - Drugs for Immediate Use or Stockpiling [2019-05-10]
Notice of Compliance (NOC) Data Extracts [2019-05-10]
Regulatory Decision Summary for Modification of MSM Blood Donor Deferral [2019-05-07]
Product Monograph Brand Safety Updates - March 2019 [2019-05-06]
Keytruda - Notice of Compliance with Conditions - Qualifying Notice [2019-05-07]
Register of Innovative Drugs [2019-05-03]
Notice of Compliance (NOC) Data Extracts [2019-05-03]
Release of Guidance Document: Regulatory requirements for Drug Identification Numbers (DINs) [2019-05-03]
Updated Register of Certificates of Supplementary Protection and Applications [2019-05-03]
Updated List of Drugs for an Urgent Public Health Need [2019-05-03]
DPD Extracts [2019-05-01]

April

Generic Submissions Under Review [2019-04-30]
Submissions Under Review [2019-04-30]
Updated List of Drugs for an Urgent Public Health Need [2019-04-30]
Scientific Advisory Committee on Health Products for Women - Meeting Announcement - May 16-17, Membership List and Biographies [2019-04-26]
Notice of Compliance (NOC) Data Extracts [2019-04-26]
Notice of Consultation on the Prescription Drug List: Tramadol [2019-04-24]
Notice of Compliance (NOC) Data Extracts [2019-04-18]
Register of Innovative Drugs [2019-04-18]
Libtayo - Notice of Compliance with Conditions - Qualifying Notice [2019-04-17]
Post-Authorization Activity Table (PAAT) for Mifegymiso [2019-04-16]
Updated Register of Certificates of Supplementary Protection and Applications [2019-04-16]
Notice: Mandatory use of the Electronic Common Technical Document (eCTD) format [2019-04-15]
Notice - Release of ICH E17: Multi-Regional Clinical Trials [2019-04-12]
Notice of Compliance (NOC) Data Extracts [2019-04-12]
Notice of Intent - Structured Product Monograph [2019-04-10]
Consultation on: Draft Guidance Document Identifying and Labelling Medicinal Ingredients and Draft Guidance Document Generic Drug Equivalence: Medicinal Ingredients [2019-04-08]
Updated Register of Certificates of Supplementary Protection and Applications [2019-04-08]
Register of Innovative Drugs [2019-04-05]
Notice of Compliance (NOC) Data Extracts [2019-04-05]
Updated Register of Certificates of Supplementary Protection and Applications [2019-04-04]
Notice: Health Canada and United States Food and Drug Administration Joint Public Consultation on International Council on Harmonisation Guidelines [2019-04-03]
Notice: Release of the guidance document E6(R2): Good Clinical Practice [2019-04-03]
Updated List of Drugs for an Urgent Public Health Need [2019-04-03]
Notice: For Consultation: Draft (Step 2) ICH Guidance: M10 Bioanalytical Validation Method [2019-04-03]
Lorbrena - Notice of Compliance with Conditions - Qualifying Notice [2019-04-02]
DPD Extracts [201-04-01]

March

Notice of Compliance (NOC) Data Extracts [2019-03-29]
Notice: Prescription Drug List (PDL): Multiple additions [2019-03-28]
Updated: Notice re: Validation rules for regulatory transactions provided to Health Canada in the electronic Common Technical Document (eCTD) format [2019-03-29]
Updated List of Drugs for an Urgent Public Health Need [2019-03-27]
Notice of Compliance (NOC) Data Extracts [2019-03-26]
Filing Submissions Electronically [2019-03-25]
Updated Fee Forms [2019-03-25]
Register of Innovative Drugs [2019-03-22]
What we heard: A summary of scanning and consultations on what's next for health product regulation
Updated Notice: Regulatory Enrolment Process (REP) Pilot for Division 1 & Division 8 (human drugs) regulatory activities [2019-03-20]
Updated Notice: eCTD Pilot for Clinical Trial Regulatory Activities - Extension [2019-03-18]
Submissions Under Review [2019-03-18]
Generic Submissions Under Review [2019-03-15]
Notice of Compliance (NOC) Data Extracts [2019-03-15]
Notice to Stakeholders: Updates to the Opioid Patient Information Handout [2019-03-15]
Clinical information on drugs and health products
Updated Register of Certificates of Supplementary Protection and Applications [2019-03-11]
Product Monograph Brand Safety Updates - February 2019 [2019-03-11]
Notice of Compliance (NOC) Data Extracts [2019-03-11]
Stop illegal marketing of drugs and devices
Updated Register of Certificates of Supplementary Protection and Applications[2019-03-05]
Notice: Prescription Drug List (PDL): Multiple additions [2019-03-05]

February

DPD Extracts [2019-03-01]
Product Monograph Brand Safety Updates – January 2019 [2019-02-28]
Updated Register of Certificates of Supplementary Protection and Applications [2019-02-27]
Guidance Document: Master Files (MFs) – Procedures and Administrative Requirements [2019-02-26]
TPD Quarterly Drug Submission Performance report for October - December 2018 [2019-02-25]
Regulatory Decision Summary for APTIOM [2019-02-25]
Summary Basis of Decision (SBD) for CABOMETYX [2019-02-25]
Regulatory Decision Summary for ERELZI [2019-02-25]
Post-Authorization Activity Table (PAAT) for Fibristal [2019-02-25]
Post-Authorization Activity Table (PAAT) for Harvoni [2019-02-25]
Post-Authorization Activity Table (PAAT) for Holkira Pak [2019-02-25]
Summary of Cancellation for Innohep Control number 199839 [2019-02-25]
Post-Authorization Activity Table (PAAT) for Keytruda [2019-02-25]
Summary Basis of Decision (SBD) for KYMRIAH [2019-02-25]
Post-Authorization Activity Table (PAAT) for Mekinist [2019-02-25]
Updated Register of Certificates of Supplementary Protection and Applications [2019-02-22]
Generic Submissions Under Review [2019-02-22]
Notice of Compliance (NOC) Data Extracts [2019-02-22]
Register of Innovative Drugs [2019-02-21]
Submissions Under Review [2019-02-21]
Register of Innovative Drugs [2019-02-15]
Notice of Compliance (NOC) Data Extracts [2019-02-15]
Updated Register of Certificates of Supplementary Protection and Applications [2019-02-14]
Qualifying Notice for Idhifa [2019-02-11]
Summary of Cancellation for Innohep Control number 199839 [2019-02-11]
Post-Authorization Activity Table (PAAT) for Kadcyla [2019-02-11]
Regulatory Decision Summary for LUTATHERA [2019-02-11]
Post-Authorization Activity Table (PAAT) for Ofev [2019-02-11]
Regulatory Decision Summary for ORILISSA [2019-02-11]
Post-Authorization Activity Table (PAAT) for Tafinlar [2019-02-11]
Summary basis of decision for Xermelo [2019-02-11]
Post-Authorization Activity Table (PAAT) for Zepatier [2019-02-11]
Summary Basis of Decision (SBD) for ALUNBRIG [2019-02-11]
Post-Authorization Activity Table (PAAT) for Bexsero [2019-02-11]
Post-Authorization Activity Table (PAAT) for Bosulif [2019-02-11]
Post-Authorization Activity Table (PAAT) for Cosentyx [2019-02-11]
Register of Innovative Drugs [2019-02-08]
Updated Questions and Answers: Prescription Opioids – Sticker and Handout Requirements for Pharmacists and Practitioners [2019-02-07]
Updated: Validation rules for regulatory transactions provided to Health Canada in the electronic Common Technical Document (eCTD) format [2019-02-07]
Updated Register of Certificates of Supplementary Protection and Applications [2019-02-05]
Updated: Validation rules for regulatory transactions provided to Health Canada in the "non-eCTD electronic-only" format [2019-02-05]
Post-Authorization Activity Table (PAAT) for Adynovate [2019-02-05]
Post-Authorization Activity Table (PAAT) for BAT [2019-02-05]
Post-Authorization Activity Table (PAAT) for Breo Ellipta [2019-02-05]
Post-Authorization Activity Table (PAAT) for Carbaglu [2019-02-05]
Post-Authorization Activity Table (PAAT) for Constella [2019-02-05]
Post-Authorization Activity Table (PAAT) for Egrifta [2019-02-05]
Post-Authorization Activity Table (PAAT) for Esbriet [2019-02-05]
Post-Authorization Activity Table (PAAT) for Galexos [2019-02-05]
Post-Authorization Activity Table (PAAT) for Grastofil [2019-02-05]
Post-Authorization Activity Table (PAAT) for Ibrance [2019-02-05]
Updated Notice: Mandatory Use of the Electronic Common Technical Guidance (eCTD) Format [2019-02-05]
DPD Extracts [2019-02-01]
Register of Innovative Drugs [2019-02-01]

January

Updated Register of Certificates of Supplementary Protection and Applications [2019-01-31]
Scientific Advisory Committee on Respiratory And Allergy Therapies - Record Of Proceedings (SAC-RAT) [2019-01-31]
Scientific Advisory Committee on Health Products for Women: Nomination Call for Members and Terms of Reference [2019-01-30]
Notice: Discontinuation of Acknowledgement Letters for Regulatory Activities received by Health Canada [2019-01-30]
Register of Innovative Drug [2019-01-28]
Notice of Compliance (NOC) Data Extracts [2019-01-25]
Updated Register of Certificates of Supplementary Protection and Applications [2019-01-25]
Release of the Draft Guidance Document: Regulatory Requirements for Drug Identification Numbers (DINs) [2019-01-25]
Regulatory Decision Summary for ADCETRIS [2019-01-24]
Post-Authorization Activity Table (PAAT) for Admelog [2019-01-24]
Summary basis of decision for Aimovig [2019-01-24]
Regulatory Decision Summary for BELSOMRA [2019-01-24]
Regulatory Decision Summary for BIOTHRAX [2019-01-24]
Regulatory Decision Summary for DARZALEX [2019-01-24]
Regulatory Decision Summary for FOLOTYN [2019-01-24]
Post-Authorization Activity Table (PAAT) for Kalydeco [2019-01-24]
Post-Authorization Activity Table (PAAT) for Neupro [2019-01-24]
Regulatory Decision Summary for TAKHZYRO [2019-01-24]
Summary Basis of Decision (SBD) for XYDALBA [2019-01-24]
Post-Authorization Activity Table (PAAT) for Zonovate [2019-01-24]
Submissions Under Review [2019-01-22]
Updated List of Drugs for an Urgent Public Health Need [2019-01-22]
Updated Register of Certificates of Supplementary Protection and Applications [2019-01-18]
Updated List of Drugs for an Urgent Public Health Need [2019-01-18]
Notice of Compliance (NOC) Data Extracts [2019-01-18]
Post-Authorization Activity Table (PAAT) for Tudorza Genuair [2019-01-17]
Regulatory Decision Summary for XERMELO [2019-01-17]
Post-Authorization Activity Table (PAAT) for Xofigo [2019-01-17]
Regulatory Decision Summary for OXYCODONE (*XTAMPZA ER) [2019-01-17]
Consultation Notice: Health Canada Requests Feedback on Potential Impacts and Uses if Company Names were added to the Generic Submissions Under Review List [2019-01-17]
Post-Authorization Activity Table (PAAT) for Pheburane [2019-01-17]
Post-Authorization Activity Table (PAAT) for Plegridy [2019-01-17]
Post-Authorization Activity Table (PAAT) for Pomalyst [2019-01-17]
Summary Basis of Decision (SBD) for RAYALDEE [2019-01-17]
Post-Authorization Activity Table (PAAT) for Shingrix [2019-01-17]
Post-Authorization Activity Table (PAAT) for Signifor [2019-01-17]
Post-Authorization Activity Table (PAAT) for Strensiq [2019-01-17]
Regulatory Decision Summary for SUBLOCADE [2019-01-17]
Post-Authorization Activity Table (PAAT) for Sylvant [2019-01-17]
Post-Authorization Activity Table (PAAT) for Tafinlar [2019-01-17]
Post-Authorization Activity Table (PAAT) for Tecentriq [2019-01-17]
Regulatory Decision Summary for TRAJENTA [2019-01-17]
Updated Register of Certificates of Supplementary Protection and Applications [2019-01-16]
Notice for Consultation – Proposed new regulatory activity types for transactions filed to the Marketed Health Products Directorate (MHPD) [2019-01-15]
Post-Authorization Activity Table (PAAT) for Fycompa [2019-01-14]
Regulatory Decision Summary for Gilenya [2019-01-14]
Summary Basis of Decision (SBD) for Hemlibra [2019-01-14]
Post-Authorization Activity Table (PAAT) for Idelvion [2019-01-14]
Regulatory Decision Summary for Invokana [2019-01-14]
Regulatory Decision Summary for JIVI [2019-01-14]
Post-Authorization Activity Table (PAAT) for Kevzara [2019-01-14]
Summary of Cancellation for NUCALA (Control number 212242) [2019-01-14]
Post-Authorization Activity Table (PAAT) for Obizur [2019-01-14]
Summary Basis of Decision for Olumiant [2019-01-14]
Post-Authorization Activity Table (PAAT) for Orfadin [2019-01-14]
Regulatory Decision Summary for Perjeta [2019-01-14]
Updated List of Drugs for an Urgent Public Health Need [2019-01-11]
Notice of Compliance (NOC) Data Extracts [2019-01-11]
Post-Authorization Activity Table (PAAT) for Afstyla [2019-01-10]
Post-Authorization Activity Table (PAAT) for Anoro Ellipta [2019-01-10]
Regulatory Decision Summary for Brineura [2019-01-10]
Post-Authorization Activity Table (PAAT) for Brivlera [2019-01-10]
Regulatory Decision Summary for Crysvita [2019-01-10]
Post-Authorization Activity Table (PAAT) for Dotarem [2019-01-10]
Post-Authorization Activity Table (PAAT) for Duavive [2019-01-10]
Post-Authorization Activity Table (PAAT) for Elelyso [2019-01-10]
Post-Authorization Activity Table (PAAT) for Empliciti [2019-01-10]
Post-Authorization Activity Table (PAAT) for Entresto [2019-01-10]
Post-Authorization Activity Table (PAAT) for Esbriet [2019-01-10]
Post-Authorization Activity Table (PAAT) for Forxiga [2019-01-10]
Updated Register of Certificates of Supplementary Protection and Applications [2019-01-10]
Product Monograph Brand Safety Updates – December 2018 [2019-01-10]
Register of Innovative Drugs [2019-01-07]
DPD Extracts [2019-01-02]
Notice of Compliance (NOC) Data Extracts [2019-01-04]