What's new: Drug products

For industry information about COVID-19, visit our COVID-19 Drugs and vaccines section.

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

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.

COVID-19

November

October 2020

September 2020

August 2020

July 2020

June 2020

May 2020

April 2020

2020

November

October

September

August

July

June

May

April

Guidance Document on the Distribution of Drugs as Samples [2020-04-29]

List incorporated by reference [2020-04-29]

Updated Register of Certificates of Supplementary Protection and Applications [2020-04-29]

Updated List of Drugs for an Urgent Public Health Need [2020-04-24]

Register of Innovative Drugs [2020-04-24]

Updated Notice: Regulatory Enrolment Process (REP) Non-Functional Pilot for Clinical Trials [2020-04-22]

Updated Register of Certificates of Supplementary Protection and Applications [2020-04-21]

Summary Basis of Decision (SBD) for Aklief [2020-04-20]

Summary Basis of Decision (SBD) for Galli Eo [2020-04-20]

Summary Basis of Decision (SBD) for Intrarosa [2020-04-20]

Summary Basis of Decision (SBD) for Lokelma [2020-04-20]

Summary Basis of Decision (SBD) for Netspot [2020-04-20]

Summary Basis of Decision (SBD) for Trazimera [2020-04-20]

Summary Basis of Decision (SBD) for Ultomiris [2020-04-20]

Summary Basis of Decision (SBD) for Xospata [2020-04-20]

Notice of Compliance (NOC) Data Extracts [2020-04-17]

Product Monograph Brand Safety Updates - March 2020 [2020-04-17]

Submissions Under Review [2020-04-17]

Generic Submissions Under Review [2020-04-16]

Register of Innovative Drugs [2020-04-14]

Guidance Document - Preparation of Regulatory Activities in eCTD Format [2020-04-14]

Certificate of Supplementary Protection (CSP) Application Form [2020-04-09]

Notice of Compliance (NOC) Data Extracts [2020-04-06]

Funding and Fees [2020-04-01]

DPD Extracts [2020-04-01]

Updated List of Drugs for an Urgent Public Health Need [2020-04-01]

Guidance Document: Drug Identification Numbers for Schedule C Drugs (Radiopharmaceuticals and Kits) [2020-04-01]

March

Register of Innovative Drugs [2020-03-31]

Submissions Under Review [2020-03-30]

Guidance Document Questions and Answers: Plain Language Labelling Regulations for Non-prescription Drugs [2020-03-31]

Notice: Mandatory use of the Regulatory Enrolment Process (REP) as of October 1, 2020 [2020-03-30]

Post-Notice of Compliance (NOC) Changes: Framework Document (Pharmaceutical, biologic and radiopharmaceutical drugs for human use only) [2020-03-30]

Generic Submissions Under Review [2020-03-30]

Notice - Notification of Safety Labelling Changes to the Product Monographs of Pharmaceutical Drug Products [2020-03-30]

Product Monograph Brand Safety Updates - February 2020 [2020-03-18]

Register of Innovative Drugs [2020-03-26]

Administrative Processing of Submissions and Applications Involving Human or Disinfectant Drugs [2020-03-26]

Register of Innovative Drugs [2020-03-23]

Update: Notice: Health Canada and United States Food and Drug Administration Joint Public Consultation on the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guidelines [2020-03-20]

Notice: Health Canada and United States Food and Drug Administration Joint Public Consultation on the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guidelines [2020-03-20]

Guidance for Completing the Drug Submission Application Form (applicable on or after April 1st, 2019) [2020-03-20]

Notice of Compliance (NOC) Data Extracts [2020-03-20]

How to Pay Fees for Health Products [2019-03-20]

Notice: Expedited Review of Health Product Submissions and Applications to address COVID-19 [2020-03-18]

Register of Innovative Drugs [2020-03-13]

TPD, BGTD and NNHPD Quarterly Drug Submission Performance Report for Q3-2019-2020

Updated Register of Certificates of Supplementary Protection and Applications [2020-03-10]

Notice: Health Canada and United States Food and Drug Administration Joint Public Consultation on the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guidelines [2020-03-05]

Notice of Compliance (NOC) Extracts [2020-03-06]

Register of Innovative Drugs [2020-03-06]

Register of Innovative Drugs [2020-03-05]

DPD Extracts [2020-03-03]

Rozlytrek - Notice of Compliance with Conditions - Qualifying Notice [2020-03-03]

February

Notice of Compliance (NOC) Data Extracts [2020-02-28]

Register of Innovative Drugs [2020-02-27]

Notice: Release of Draft Guidance Document for Consultation: Comparative Pharmacokinetic Studies for Orally Inhaled Products [2020-02-26]

Generic Submissions Under Review [2020-02-24]

Submissions Under Review [2020-02-24]

Notice of Compliance (NOC) Data Extracts [2020-02-21]

Notice: Implementation of eCTD for Clinical Trial Regulatory Activities [2020-02-19]

Updated Register of Certificates of Supplementary Protection and Applications [2020-02-17]

Notice of Compliance (NOC) Data Extracts [2020-02-14]

Register of Innovative Drugs [2020-02-14]

Product Monograph Brand Safety Updates - January 2020 [2020-02-14]

Notice: Prescription Drug List (PDL): Multiple Additions [2020-02-13]

Updated Register of Certificates of Supplementary Protection and Applications [2020-02-10]

Notice of Compliance (NOC) Data Extracts [2020-02-07]

Summary Basis of Decision - Balversa [2020-02-05]

Summary Basis of Decision - Nerlynx [2020-02-05]

Summary Basis of Decision - Trulance [2020-02-05]

DPD Extracts [2020-02-03]

January

Notice of Compliance (NOC) Data Extracts [2020-01-31]

Updated Register of Certificates of Supplementary Protection and Applications [2020-01-29]

Summary Basis of Decision - Calquence [2020-01-28]

Summary Basis of Decision - Emgality [2020-01-28]

Summary Basis of Decision - Talzenna [2020-01-28]

Summary Basis of Decision - Tibella [2020-01-28]

Summary Basis of Decision - Vitrakvi [2020-01-28]

Register of Innovative Drugs [2020-01-27]

Notice of Compliance (NOC) Data Extracts [2020-01-24]

Product Monograph Brand Safety Updates - December 2019 [2020-01-24]

Notice of Compliance (NOC) Data Extracts [2020-01-17]

Notice: Product Monograph Implementation Plans [2020-01-13]

Updated Register of Certificates of Supplementary Protection and Applications [2020-01-10]

Notice of Compliance (NOC) Data Extracts [2020-01-10]

Register of Innovative Drugs [2020-01-10]

Notice of Compliance (NOC) Data Extracts [2020-01-06]

Register of Innovative Drugs [2020-01-06]

Summary Basis of Decision - Dacogen [2020-01-06]

Summary Basis of Decision - Esperoct [2020-01-06]

Post-Authorization Activity Table (PAAT) - Cerdelga [2020-01-06]

Post-Authorization Activity Table (PAAT) - Eucrisa [2020-01-06]

Post-Authorization Activity Table (PAAT) - Fetzima [2020-01-06]

Post-Authorization Activity Table (PAAT) - Alecensaro [2020-01-06]

Post-Authorization Activity Table (PAAT) - Iclusig [2020-01-06]

Post-Authorization Activity Table (PAAT) - Imbruvica [2020-01-06]

Post-Authorization Activity Table (PAAT) - Kisqali [2020-01-06]

Post-Authorization Activity Table (PAAT) - Genvoya [2020-01-06]

Post-Authorization Activity Table (PAAT) - Lenvima [2020-01-06]

Post-Authorization Activity Table (PAAT) - Giotrif [2020-01-06]

Post-Authorization Activity Table (PAAT) - Mictoryl [2020-01-06]

Post-Authorization Activity Table (PAAT) - Monoferric [2020-01-06]

Post-Authorization Activity Table (PAAT) - Olumiant [2020-01-06]

Post-Authorization Activity Table (PAAT) - Maviret [2020-01-06]

DPD Extracts [2020-01-02]

2019

December

November

October

September

August

July

June

May

April

March

February

January

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