What's new: Biologics, radiopharmaceuticals and genetic therapies

Subscribe

Subscribe to our RSS Feeds

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
Association Meetings: Biologics and Genetic Therapies Directorate
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.
National Vaccine Catalogue: Repository of authorized vaccines in Canada with product details and standardized terminology

COVID-19

Summary Basis of Decision for Nuvaxovid XBB.1.5 [2023-12-20]
Summary Basis of Decision for Comirnaty Omicron XBB.1.5 [2023-12-08]
Summary Basis of Decision for Spikevax XBB.1.5 [2023-12-08]
Authorization of Novavax Nuvaxovid COVID-19 vaccine for the Omicron XBB.1.5 subvariant [2023-12-05]
Authorization of Pfizer-BioNTech Comirnaty Monovalent COVID-19 vaccine for the Omicron XBB.1.5 subvariant [2023-09-28]
Authorization of Moderna Spikevax Monovalent COVID-19 vaccine for the Omicron XBB.1.5 subvariant [2023-09-12]
Pfizer-BioNTech Comirnaty bivalent BA. 4/5 authorized as a primary series COVID-19 vaccine for individuals 5 years of age and older [2023-07-06]
Authorization of Moderna Spikevax Bivalent (BA.4/5) COVID-19 vaccine booster for 6 to 17 year olds [2023-05-18]
Authorization of Moderna Spikevax Bivalent (BA.1) COVID-19 vaccine booster for 6 to 17 year olds [2023-02-17]
Health Canada is updating the COVID-19 clinical trial review time and is returning to the standard 30 day review [2023-01-27]
Authorization of Moderna Spikevax COVID-19 vaccine booster dose for adolescents aged 12 to 17 years [2023-01-12]
Summary Basis of Decision (SBD) for COMIRNATY ORIGINAL/OMICRON BA.1 [2022-12-19]
Summary Basis of Decision (SBD) for COMIRNATY ORIGINAL & OMICRON BA.4/BA.5 [2022-12-05]
Updates to the Guidance on amendments to the Food and Drug Regulations for drugs for use in relation to COVID-19 [2022-12-16]
Authorization of Pfizer-BioNTech Comirnaty Original and Omicron BA.4/BA.5 bivalent COVID-19 vaccine booster dose for children ages 5 to 11 years [2022-12-09]
Authorization of Novavax Nuvaxovid COVID-19 vaccine for adolescent ages 12 to 17 years [2022-12-06]
Authorization of Novavax Nuvaxovid COVID-19 vaccine booster [2022-11-17]
Authorization of Moderna Spikevax Original and Omicron BA.4/BA.5 bivalent COVID-19 vaccine booster [2022-11-03]
Authorization of Pfizer-BioNTech Comirnaty Original and Omicron BA.1 bivalent COVID-19 vaccine booster [2022-10-21]
Evusheld COVID-19 expanded indication [2022-10-18]
Actemra COVID-19 treatment authorization [2022-10-13]
Authorization of Pfizer-BioNTech Comirnaty Original and Omicron BA.4/BA.5 bivalent COVID-19 vaccine booster [2022-10-07]
Authorization of Pfizer-BioNTech Comirnaty COVID-19 vaccine for children ages 6 months to 5 years [2022-09-09]
Authorization of Moderna Spikevax Bivalent COVID-19 vaccine booster [2022-09-01]
Authorization of Pfizer-BioNTech Comirnaty COVID-19 vaccine first booster dose for children ages 5 to 11 years [2022-08-19]
Janssen Jcovden (Johnson & Johnson) COVID-19 vaccine brand name authorization [2022-08-05]
Summary Basis of Decision (SBD) for EVUSHELD [2022-07-22]
Authorization of Moderna Spikevax COVID-19 vaccine for children ages 6 months to 5 years [2022-07-14]
Summary Basis of Decision (SBD) for NUVAXOVID [2022-05-06]
Summary Basis of Decision (SBD) for COVIFENZ [2022-05-04]
Remdesivir approved for treating COVID-19 in an outpatient setting [2022-04-22]
Evusheld COVID-19 treatment [2022-04-14]
Authorization of Moderna Spikevax COVID-19 vaccine for children ages 6-11 [2022-03-17]
Notice: Clinical trials for medical devices and drugs relating to COVID-19 regulations [2022-03-02]
Notice of updated guidance: Applications for COVID-19 drug clinical trials under the Regulations [2022-03-02]
Notice: Period reduced for keeping clinical trial records for drugs and natural health products [2022-03-02]
Medicago Covifenz COVID-19 vaccine [2022-02-24]
Novavax Nuvaxovid COVID-19 vaccine [2022-02-17]
Authorization of Pfizer-BioNTech Comirnaty COVID-19 vaccine for children ages 5-11 [2021-11-19]
Guidance for market authorization requirements for COVID-19 drugs [2021-10-29]
Pfizer-BioNTech Comirnaty COVID-19 vaccine brand name authorization and transition into Food and Drug Regulations [2021-09-16]
Moderna Spikevax COVID-19 vaccine brand name authorization and transition into Food and Drug Regulations [2021-09-16]
AstraZeneca Vaxzevria COVID-19 vaccine brand name change through the Interim Order [2021-09-16]
Access Consortium: Alignment with ICMRA consensus on immunobridging for authorizing new COVID-19 vaccines [2021-09-15]
Summary Basis of Decision (SBD) for SOTROVIMAB [2021-09-10]
Summary Basis of Decision (SBD) for CASIRIVIMAB AND IMDEVIMAB [2021-07-20]
Interim Order No. 2 Respecting Clinical Trials for Medical Devices and Drugs Relating to COVID-19: Notice [2021-05-03]
Applications for COVID-19 drug and medical device clinical trials under the interim order: Notice of updated guidance documents [2021-05-03]
COVID-19 clinical trials IO and clinical trials records retention: Consultation report [2021-04-16]
Summary Basis of Decision (SBD) for JANSSEN COVID-19 VACCINE [2021-03-31]
Updated requirements for COVID-19 drug authorizations: Notice [2021-03-31]
What was heard: Consultation on interim order transition for tools to address drug and medical device shortages [2021-03-17]
Summary Basis of Decision (SBD) for AstraZeneca COVID-19 Vaccine [2021-03-10]
Janssen COVID-19 vaccine [2021-03-05]
Access Consortium guidance on modifications to COVID-19 vaccines to address new variants of coronavirus [2021-03-04]
Second Interim Order on Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19 [2021-03-01]
AstraZeneca COVID-19 vaccine [2021-02-26]
Summary Basis of Decision (SBD) for Bamlanivimab for Injection [2021-01-08]
Adverse Events Following Immunization Report [2020-01-08]
Summary Basis of Decision (SBD) for the Moderna COVID-19 Vaccine [2021-01-06]
Moderna COVID-19 vaccine [2020-12-23]
Pfizer-BioNTech COVID-19 vaccine [2020-12-09]
Vaccine development and approval in Canada (Infographic) [2020-12-08]
COVID-19 mRNA vaccines [2020-12-08]
Viral vector-based vaccines for COVID-19 [2020-12-08]
Access Consortium statement on COVID-19 vaccines evidence [2020-12-03]
Notice to stakeholders: Consultation on amending the Food and Drug Regulations to expedite access to COVID-19 drugs [2020-12-01]
Consultation: Amending the Food and Drug Regulations to provide expedited access to COVID-19 drugs [2020-12-01]
Guidance for market authorization requirements for COVID-19 vaccines [2020-11-21]
Interim Order Respecting the Prevention and Alleviation of Shortages of Drugs in Relation to COVID-19 [2020-10-19]
Notice Interim order on preventing and alleviating drug shortages in relation to COVID-19 [2020-10-19]
Drug and vaccine authorizations for COVID-19: List of applications received [update 2020-10-01]
Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 [2020-09-17]
Interim order and guidance document to import, sell and advertise COVID-19 related drugs and vaccines: Notice [2020-09-17]
Drug and vaccine authorizations for COVID-19 [2020-09-17]
Good Manufacturing Practices and COVID-19 [2020-08-07]
Drug establishment licences and COVID-19 [2020-08-07]
Changes to notification requirements for biologic drugs: Notice to industry [2020-07-08]
Health Canada's regulatory response to COVID-19: Access to health products [2020-07-03]
Interim Order Respecting Clinical Trials for Medical Devices and Drugs Relating to COVID-19: Notice [2020-05-27]
Applications for COVID-19 drug and medical device clinical trials under the Interim Order: Notice release of guidance documents [2020-05-27]
Joint Statement on Clinical Trial Oversight in Canada [2020-05-27]
Clinical trials and drug safety [2020-05-27]
Drugs and vaccines for COVID-19: Overview
Australia, Canada, Singapore, Switzerland Consortium regulators pledge support to tackle COVID-19 [2020-05-05]
Engaging with international partners on COVID-19 [2020-04-30]
International Coalition of Medicines Regulatory Authorities (ICMRA) statement on COVID-19 [2020-04-29]
Management of clinical trials during the COVID-19 pandemic: Notice to clinical trial sponsors [2020-04-22]
Interim Order Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19 [2020-04-05]
Exceptional importation and sale of drugs and biocides against COVID-19 [2020-04-05]
COVID-19 health product industry [2020-04-01]

2024

November

Updated Register of Certificates of Supplementary Protection and Applications [2024-11-25]
Updated Register of Certificates of Supplementary Protection and Applications [2024-11-20]
Updated: Notice to industry: Aligned reviews between Health Canada and health technology assessment organizations [2024-11-05]
Summary Basis of Decision for Beqvez [2024-11-05]
Summary Basis of Decision for Jubbonti [2024-11-05]
Summary Basis of Decision for Wyost [2024-11-05]

October

Updated: Regulatory enrolment process (REP) [2024-10-28]
Updated Register of Certificates of Supplementary Protection and Applications [2024-10-24]
Notice: Multiple additions to the Prescription Drug List (PDL) [2024-10-18]
Updated Register of Certificates of Supplementary Protection and Applications [2024-10-10]
Summary Basis of Decision for Uplizna [2024-10-09]
Summary Basis of Decision for Xenpozyme [2024-10-09]
Notice of Amendment: Iron derivatives for human use on the Prescription Drug List (PDL) [2024-10-04]

September

Updated Register of Certificates of Supplementary Protection and Applications [2024-09-23]
Qualifying notice for Imdelltra [2024-09-20]
Updated: Policy on Drug/Medical Device Combination Products - Decisions [2024-09-13]
Authorization for a third party to file a regulatory activity on behalf of the manufacturer/sponsor [2024-09-11]

August

Summary Basis of Decision for Elrexfio [2024-08-22]
Summary Basis of Decision for Myalepta [2024-08-22]
Summary Basis of Decision for Wezlana/Wezlana I.V. [2024-08-22]

July

Appendix 1: Established acceptable intake (AI) limits for N-nitrosamine impurities [2024-07-26]
Consultation: Release of Draft (Step 2) ICH guideline, ICH M14 [2024-07-24]
Summary Basis of Decision for Asparlas [2024-07-22]
Summary Basis of Decision for Jamteki [2024-07-22]
Summary Basis of Decision for Ranopto [2024-07-22]
Updated Register of Certificates of Supplementary Protection and Applications [2024-07-05]

June

Nitrosamine impurities in medications: Recalls [2024-06-19]
Updated Register of Certificates of Supplementary Protection and Applications [2024-06-19]
Updated Register of Certificates of Supplementary Protection and Applications [2024-06-12]
Updated List of Drugs for an Urgent Public Health Need [2024-06-04]
Summary Basis of Decision for Abrysvo [2024-06-03]
Summary Basis of Decision for Hemgenix [2024-06-03]

May

Updated: Guidance on nitrosamine impurities in medications [2024-05-31]
Appendix 1: Established acceptable intake (AI) limits for N-nitrosamine impurities [2024-05-31]
Consultation: Release of Draft (Step 2) ICH guideline, ICH E2D(R1) [2024-05-24]
Updated Register of Certificates of Supplementary Protection and Applications [2024-05-23]
Qualifying notice for Talvey [2024-05-17]
Updated: Technical requirements for conducting the suitability assessment of sperm and ova donors [2024-05-08]
Summary Basis of Decision for Epkinly [2024-05-06]
Summary Basis of Decision for Vyvgart [2024-05-06]

April

Notice: Multiple additions to the Prescription Drug List (PDL) [2024-04-30]
Updated Register of Certificates of Supplementary Protection and Applications [2024-04-18]
Updated Register of Certificates of Supplementary Protection and Applications [2024-04-10]

March

Appendix 1: Established acceptable intake (AI) limits for N-nitrosamine impurities [2024-03-28]
Updated Register of Certificates of Supplementary Protection and Applications [2024-03-27]
Updated Register of Certificates of Supplementary Protection and Applications [2024-03-19]
Updated: Guidance on nitrosamine impurities in medications [2024-03-15]
Guidance on interim enforcement approach for directed donations of sperm and ova [2024-03-12]
Updated Register of Certificates of Supplementary Protection and Applications [2024-03-08]
Updated Register of Certificates of Supplementary Protection and Applications [2024-03-04]

February

Notice: Multiple additions to the Prescription Drug List (PDL) [2024-02-28]
Updated List of Drugs for an Urgent Public Health Need [2024-02-28]
Notice: Release of notice for (Step 4) ICH E19: A Selective Approach to Safety Data Collection in Specific Late Stage Pre-approval or Post-approval Clinical Trials [2024-02-27]
Updated Register of Certificates of Supplementary Protection and Applications [2024-02-27]
Notice: Expansion of the Generic Submissions Under Review List [2024-02-23]
Summary Basis of Decision for Axberi/Axberi HP [2024-02-20]
Summary Basis of Decision for Evkeeza [2024-02-20]
Summary Basis of Decision for Nuvaxovid XBB.1.5 [2024-02-20]
Updated Register of Certificates of Supplementary Protection and Applications [2024-02-09]
Updated Register of Certificates of Supplementary Protection and Applications [2024-02-07]

January

Updated: Regulatory enrolment process [2024-01-30]
Qualifying notice for Elrexfio [2024-01-26]
Notice: Application of the definition of Canadian Reference Product [2024-01-26]
Updated Register of Certificates of Supplementary Protection and Applications [2024-01-25]
Summary Basis of Decision for Imjudo [2024-01-15]
Summary Basis of Decision for Opdualag [2024-01-15]
Updated Register of Certificates of Supplementary Protection and Applications [2024-01-09]
Update to the Guidance Document: Master Files (MFs) - Procedures and Administrative Requirements [2024-01-02]

2023

December

Updated Register of Certificates of Supplementary Protection and Applications [2023-12-27]
Notice – Implementation of ICH E19: A selective approach to safety data collection in specific late-stage pre-approval or post-approval clinical trials [2023-12-21]
Summary Basis of Decision for Arexvy [2023-12-08]
Summary Basis of Decision for Comirnaty Omicron XBB.1.5 [2023-12-08]
Summary Basis of Decision for Ondexxya [2023-12-08]
Summary Basis of Decision for Sogroya [2023-12-08]
Summary Basis of Decision for Spikevax XBB.1.5 [2023-12-08]
Updated Register of Certificates of Supplementary Protection and Applications [2023-12-07]
Qualifying notice for Epkinly [2023-12-04]
Notice: Release of revised notice for (Step 4) ICH S1B(R1): Testing for Carcinogenicity of Pharmaceuticals [2023-12-01]

November

Updated Register of Certificates of Supplementary Protection and Applications [2023-11-10]

October

Updated: Guidance on nitrosamine impurities in medications [2023-10-20]
Summary Basis of Decision for Omvoh [2023-10-13]
Summary Basis of Decision for Prehevbrio [2023-10-13]
Summary Basis of Decision for Tecvayli [2023-10-13]

September

August

Notice: Multiple additions to the Prescription Drug List (PDL) [2023-08-30]
Updated List of Drugs for an Urgent Public Health Need [2023-08-24]
Updated Register of Certificates of Supplementary Protection and Applications [2023-08-15]
Updated Register of Certificates of Supplementary Protection and Applications [2023-08-09]
Qualifying notice for Tecvayli [2023-08-03]

July

Updated: Guidance on nitrosamine impurities in medications [2023-07-28]
Updated Register of Certificates of Supplementary Protection and Applications [2023-07-28]
Notice: Release of (Step 4) ICH S12 Guideline - Nonclinical Biodistribution Considerations for Gene Therapy Products [2023-07-21]
Updated Register of Certificates of Supplementary Protection and Applications [2023-07-17]
Qualifying notice for Ondexxya [2023-07-05]

June

Updated: Regulatory enrolment process [2023-06-27]
Summary Basis of Decision for Beyfortus [2023-06-27]
Summary Basis of Decision for Locametz [2023-06-27]
Summary Basis of Decision for Spevigo [2023-06-27]
Updated: Guidance on procedures and administrative requirements for master files [2023-06-26]
Consultation: Release of Draft (Step 2) ICH guideline, ICH E6(R3) [2023-06-21]
S1B(R1): Health Canada Notice [2023-06-20]
S1B(R1): Guideline - Testing for Carcinogenicity of Pharmaceuticals [2023-06-20]
Summary Basis of Decision (SBD) for Alhemo [2023-06-06]
Summary Basis of Decision (SBD) for Carvykti [2023-06-06]
Summary Basis of Decision (SBD) for Columvi [2023-06-06]
Summary Basis of Decision (SBD) for Vegzelma [2023-06-06]

May

Updated Register of Certificates of Supplementary Protection and Applications [2023-05-18]
Notice: Publication of the Guidance Document: Certificates of Supplementary Protection [2023-05-12]
Updated Register of Certificates of Supplementary Protection and Applications [2023-05-05]
Summary Basis of Decision (SBD) for ELONOX/ELONOX HP [2023-05-05]

April

Updated Register of Certificates of Supplementary Protection and Applications [2023-05-23]
Updated Register of Certificates of Supplementary Protection and Applications [2023-05-03]
Qualifying notice for Columvi [2023-04-17]
Nitrosamine impurities in medications: Guidance [2023-04-17]
Updated Register of Certificates of Supplementary Protection and Applications [2023-04-12]
Updated Register of Certificates of Supplementary Protection and Applications [2023-04-04]
Updated List of Drugs for an Urgent Public Health Need [2023-04-03]

March

Summary Basis of Decision (SBD) for ERVEBO [2023-03-31]
Updated Register of Certificates of Supplementary Protection and Applications [2023-03-20]
Updated Register of Certificates of Supplementary Protection and Applications [2023-03-15]
Summary Basis of Decision (SBD) for ILLUCCIX [2023-03-10]
Summary Basis of Decision (SBD) for RYMTI [2023-03-10]
Qualifying notice for Carvykti [2023-03-07]
Consultation period extended until April 26, 2023 for proposed agile regulations and guidance for licensing drugs and medical devices [2023-03-06]
Updated Register of Certificates of Supplementary Protection and Applications [2023-03-06]
Updated Register of Certificates of Supplementary Protection and Applications [2023-03-01]

February

Consultation: Release of Draft (Step 2) ICH guideline, ICH M13 [2023-02-24]
Summary Basis of Decision (SBD) for MYXREDLIN [2023-02-14]
Summary Basis of Decision (SBD) for PLUVICTO [2023-02-14]
Updated Register of Certificates of Supplementary Protection and Applications [2023-02-07]
Updated Register of Certificates of Supplementary Protection and Applications [2023-02-01]

January

Qualifying notice for Opdivo [2023-01-30]
Qualifying notice amendment for Opdivo [2023-01-25]
Summary Basis of Decision (SBD) for TEZSPIRE [2023-01-20]
Notice: Release of (Step 4) ICH M10 Guideline and Q&A Document - Bioanalytical Method Validation and Study Sample Analysis [2023-01-20]
Notice: Joint Health Canada, Canada and FDA, United States Public Consultation on ICH [2023-01-17]
Updated Register of Certificates of Supplementary Protection and Applications [2023-01-16]

2022

December

Summary Basis of Decision (SBD) for COMIRNATY ORIGINAL/OMICRON BA.1 [2022-12-19]
Summary Basis of Decision (SBD) for COMIRNATY ORIGINAL & OMICRON BA.4/BA.5 [2022-12-05]
Qualifying notice for Kymriah [2022-12-30]
Updated Register of Certificates of Supplementary Protection and Applications [2022-12-29]
Consultation on proposed agile regulations and guidance for licensing drugs and medical devices [2022-12-16]
Updated Register of Certificates of Supplementary Protection and Applications [2022-12-16]

November

Updated Register of Certificates of Supplementary Protection and Applications [2022-11-28]
Summary Basis of Decision (SBD) for POTELIGEO [2022-11-24]
Updated Register of Certificates of Supplementary Protection and Applications [2022-11-18]
Consultation: Release of Draft (Step 2) ICH M11 guideline, technical specification and template [2022-11-18]
Updated List of Drugs for an Urgent Public Health Need [2022-11-17]
Updated Register of Certificates of Supplementary Protection and Applications [2022-11-09]
Updated Register of Certificates of Supplementary Protection and Applications [2022-11-07]
Updated: REP guidance document for Human Drugs, Veterinary Drugs and Disinfectants [2022-11-04]
Consultation: Release of Draft (Step 2) ICH guideline, ICH Q5A(R2) [2022-11-02]

October

Updated Register of Certificates of Supplementary Protection and Applications [2022-10-20]
Summary Basis of Decision (SBD) for BIMZELX [2022-10-18]
Summary Basis of Decision (SBD) for KIMMTRAK [2022-10-18]
Notice: Multiple additions to the Prescription Drug List (PDL) [2022-10-14]
Qualifying notice for Yescarta [2022-10-07]

September

Consultation Extension: Draft (Step 2) ICH Guideline E11A [2022-09-29]
Qualifying notice amendment for Imfinzi [2022-09-29]
Updated List of Drugs for an Urgent Public Health Need [2022-09-27]
Summary Basis of Decision (SBD) for BREYANZI [2022-09-27]
Summary Basis of Decision (SBD) for BYOOVIZ [2022-09-27]
Summary Basis of Decision (SBD) for PREVNAR 20 [2022-09-27]
Summary Basis of Decision (SBD) for SEMGLEE [2022-09-27]
Summary Basis of Decision (SBD) for VABYSMO [2022-09-27]
Updated Register of Certificates of Supplementary Protection and Applications [2022-09-21]
Updated: Guidance document preparation of regulatory activities in non-eCTD format [2022-09-15]
Updated Register of Certificates of Supplementary Protection and Applications [2022-09-14]
Updated: REP guidance document for human drugs, veterinary drugs and disinfectants [2022-09-02]
Updated: Guidance on nitrosamine impurities in medications [2022-09-01]

August

Notice: Implementation of (Step 4) ICH Q3D(R2) Guideline - Revision of Q3D(R1) for cutaneous and transdermal products [2022-08-29]
Health Canada recommendations for implementation of the Revised ICH Harmonised Guideline for Elemental Impurities Q3D(R2) for cutaneous and transdermal products [2022-08-29]
Updated: Clinical Trial Applications in eCTD format [2022-08-26]
Updated Register of Certificates of Supplementary Protection and Applications [2022-08-19]
Summary Basis of Decision (SBD) for PALYNZIQ [2022-08-17]
Summary Basis of Decision (SBD) for RYBREVANT [2022-08-17]
Updated Register of Certificates of Supplementary Protection and Applications [2022-08-11]
Updated Register of Certificates of Supplementary Protection and Applications [2022-08-04]
Health product highlights 2021: Helping you maintain and improve your health [2022-08-03]
Notice: Revision to the Guidance Document Management of Drug Submissions and Applications (August 2022) [2022-08-02]

July

Consultation: Release of Draft (Step 2) ICH guideline, ICH M12 [2022-07-29]
Updated Register of Certificates of Supplementary Protection and Applications [2022-07-28]
Consultation: Exceptions to the Prescription Drug List [2022-07-28]
Updated Register of Certificates of Supplementary Protection and Applications [2022-07-26]
PDD/BRDD/NNHPD Drug Submission Performance Annual Report – Fiscal Year 2021-2022 [2022-07-25]
Summary Basis of Decision (SBD) for EVUSHELD [2022-07-22]
Summary Basis of Decision (SBD) for HYQVIA [2022-07-22]
Summary Basis of Decision (SBD) for ONTRUZANT [2022-07-22]
Summary Basis of Decision (SBD) for OXLUMO [2022-07-22]
Summary Basis of Decision (SBD) for RYBREVANT [2022-07-22]
Summary Basis of Decision (SBD) for NETVISION [2022-07-04]

June

May

April

Qualifying notice for Rybrevant [2022-04-28]
Qualifying notice for Gardasil 9 [2022-04-26]
Blood safety in Canada: Restriction lifted for men who have sex with men [2022-04-28]
Notice: Interim implementation of electronic labelling for human prescription drugs [2022-04-22]
Updated List of Drugs for an Urgent Public Health Need [2022-04-12]
Updated List of Drugs for an Urgent Public Health Need [2022-04-07]
Keeping Health Products In Canada Safe [2022-04-05]
Updated Register of Certificates of Supplementary Protection and Applications [2022-04-04]
Qualifying notice for Bavencio [2022-04-04]

March

Updated Register of Certificates of Supplementary Protection and Applications [2022-03-28]
Updated Register of Certificates of Supplementary Protection and Applications [2022-03-23]
Expert advisory panel on sexual behaviour-based screening criteria for blood and plasma [2022-03-22]
Summary Basis of Decision (SBD) for NEXVIAZYME [2022-03-21]
Summary Basis of Decision (SBD) for VAXNEUVANCE [2022-03-21]
TPD/BRDD/NNHPD Drug Submission Performance Quarterly Report for Q3-2021-2022 [2022-03-11]
Updated Register of Certificates of Supplementary Protection and Applications [2022-03-10]
Updated Register of Certificates of Supplementary Protection and Applications [2022-03-04]
Notice: Regulations amending certain regulations concerning drugs and medical devices (shortages) [2022-03-02]
Drug shortages in Canada: Regulations and guidance [2022-03-02]

February

Updated: Guidance Document - Preparation of Regulatory Activities in Non-eCTD format and Filing Submission Electronically webpage [2022-02-28]
Summary Basis of Decision (SBD) for AYBINTIO [2022-02-22]
Summary Basis of Decision (SBD) for NYPOZI [2022-02-22]
Summary Basis of Decision (SBD) for PADCEV [2022-02-22]
Summary Basis of Decision (SBD) for SAPHNELO [2022-02-22]
Updated Register of Certificates of Supplementary Protection and Applications [2022-02-17]
Summary Basis of Decision (SBD) for BAMBEVI [2022-02-11]
Summary Basis of Decision (SBD) for KIRSTY [2022-02-11]
Summary Basis of Decision (SBD) for NGENLA [2022-02-11]
Updated Register of Certificates of Supplementary Protection and Applications [2022-02-10]
Updated Register of Certificates of Supplementary Protection and Applications [2022-02-04]

January

Updated Register of Certificates of Supplementary Protection and Applications [2022-01-28]
Updated Register of Certificates of Supplementary Protection and Applications [2022-01-21]
Updated List of Drugs for an Urgent Public Health Need [2022-01-21]
Summary Basis of Decision (SBD) for TECARTUS [2022-01-11]
Summary Basis of Decision (SBD) for TRODELVY [2022-01-11]
Updated Register of Certificates of Supplementary Protection and Applications [2022-01-11]
Joint Notice on Collaboration between the Competition Bureau and Health Products and Food Branch of Health Canada [2022-01-10]
Updated Register of Certificates of Supplementary Protection and Applications [2022-01-06]
Guidance Document: Special Access Program for Drugs: Guidance Document for Industry and Practitioners [2022-01-05]

2021

December

TPD/BRDD/NNHPD Drug Submission Performance Quarterly Report for Q2-2021-2022 [2021-12-23]
Summary Basis of Decision (SBD) for ABECMA [2021-12-08]
Summary Basis of Decision (SBD) for MINJUVI [2021-12-08]
Summary Basis of Decision (SBD) for RIABNI [2021-12-08]
Updated Register of Certificates of Supplementary Protection and Applications [2021-12-01]

November

Updated Register of Certificates of Supplementary Protection and Applications [2021-11-25]
Updated List of Drugs for an Urgent Public Health Need [2021-11-12]
Updated Register of Certificates of Supplementary Protection and Applications [2021-11-10]
Updated List of Drugs for an Urgent Public Health Need [2021-11-09]

October

Updated Register of Certificates of Supplementary Protection and Applications [2021-10-27]
Extension: Release of draft revised guidance documents on Post-Notice of Compliance (NOC) Changes – Quality, for stakeholder consultation [2021-10-15]
Summary Basis of Decision (SBD) for ABRILADA (FORMERLY ADALIMUMAB INJECTION) [2021-10-12]
Summary Basis of Decision (SBD) for ILUMYA [2021-10-12]
Updated Register of Certificates of Supplementary Protection and Applications [2021-10-07]
Updated List of Drugs for an Urgent Public Health Need [2021-10-06]

September

Mid-year update: Health products approved in 2021
TPD/BRDD/NNHPD Drug Submission Performance Quarterly Report for Q1-2021-2022 [2021-09-29]
Updated Register of Certificates of Supplementary Protection and Applications [2021-09-24]
Qualifying Notice for Minjuvi [2021-09-20]
Summary Basis of Decision (SBD) for HULIO [2021-09-10]
Updated Register of Certificates of Supplementary Protection and Applications [2021-09-02]

August

Updated Register of Certificates of Supplementary Protection and Applications [2021-08-31]
Updated Register of Certificates of Supplementary Protection and Applications [2021-08-11]
The Drug Establishment Licensing Bulletin [2021-08-10]
Notice: Release of draft revised guidance documents on Post-Notice of Compliance (NOC) Changes – Quality, for stakeholder consultation [2021-08-06]
Consultation: Release of draft revised guidance documents on Post-Notice of Compliance (NOC) Changes – Quality, for stakeholder consultation [2021-08-06]
Updated Register of Certificates of Supplementary Protection and Applications [2021-08-05]
Summary Basis of Decision (SBD) for AMGEVITA [2021-08-03]
Summary Basis of Decision (SBD) for CASIRIVIMAB AND IMDEVIMAB [2021-08-03]
Summary Basis of Decision (SBD) for ENHERTU [2021-08-03]
Summary Basis of Decision (SBD) for REDESCA/REDESCA HP [2021-08-03]
Summary Basis of Decision (SBD) for ZIRABEV [2021-08-03]

July

Updated List of Drugs for an Urgent Public Health Need [2021-07-28]
Updated Register of Certificates of Supplementary Protection and Applications [2021-07-27]
Drug and medical device highlights 2020: Helping you maintain and improve your health [2021-07-27]
TPD/BRDD/NNHPD Annual Drug Submission Performance report – Fiscal Year 2020-2021 [2021-07-20]
Summary Basis of Decision (SBD) for TISSUEBLUE [2021-07-20]
Summary Basis of Decision (SBD) for LUXTURNA [2021-07-20]
Summary Basis of Decision (SBD) for HYRIMOZ [2021-07-20]
TPD/BRDD/NNHPD Drug Submission Performance Quarterly Report for Q4-2020-2021 [2021-07-13]
Notice: Revision to the Guidance Document: Management of Drug Submissions and Applications [2021-07-07]

June

Updated Register of Certificates of Supplementary Protection and Applications [2021-06-24]
Updated Register of Certificates of Supplementary Protection and Applications [2021-06-16]
Summary Basis of Decision (SBD) for SUPEMTEK [2021-06-10]
Summary Basis of Decision (SBD) for VYEPTI [2021-06-10]
Qualifying Notice for Abecma [2021-06-04]
Updated Register of Certificates of Supplementary Protection and Applications [2021-06-02]
Updated: Drug Product Database (DPP) Terminology [2021-06-02]

May

Notice: Prescription Drug List (PDL): Multiple Additions [2021-05-27]
Updated Register of Certificates of Supplementary Protection and Applications [2021-05-26]
Updated Register of Certificates of Supplementary Protection and Applications [2021-05-20]
Summary Basis of Decision (SBD) for INCRELEX [2021-05-12]
Summary Basis of Decision (SBD) for NYVEPRIA [2021-05-12]

April

Updated Register of Certificates of Supplementary Protection and Applications [2021-04-23]
Updated List of Drugs for an Urgent Public Health Need [2021-04-23]
Updated Register of Certificates of Supplementary Protection and Applications [2021-04-08]

March

Summary Basis of Decision (SBD) for IDACIO [2021-03-31]
Summary Basis of Decision (SBD) for INCLUNOX/INCLUNOX HP [2021-03-31]
Summary Basis of Decision (SBD) for ZOLGENSMA [2021-03-31]
Updated Register of Certificates of Supplementary Protection and Applications [2021-03-29]
Updated Register of Certificates of Supplementary Protection and Applications [2021-03-17]
Qualifying Notice for Keytruda [2021-03-17]
TPD/BRDD/NNHPD Drug Submission Performance Quarterly Report for Q3-2020-2021 [2021-03-16]
Summary Basis of Decision (SBD) for Inclunox/Inclunox HP [2021-03-10]
Summary Basis of Decision (SBD) for Idacio [2021-03-10]

February

Qualifying Notice for Opdivo [2021-02-26]
Summary Basis of Decision (SBD) for Anthim [2021-02-17]
Summary Basis of Decision (SBD) for Trurapi [2021-02-17]
Summary Basis of Decision (SBD) for Givlaari [2021-02-17]
Updated List of Drugs for an Urgent Public Health Need [2021-02-03]
Updated Register of Certificates of Supplementary Protection and Applications [2021-02-03]
Updated Register of Certificates of Supplementary Protection and Applications [2021-02-01]

January

Regulatory innovation for health products [2021-01-29]
Qualifying Notice for Verity-BCG [2021-01-29]
Summary Basis of Decision (SBD) for Noromby/Noromby HP [2021-01-28]

2020

December

Qualifying Notice for Keytruda [2020-12-30]
Summary Basis of Decision (SBD) for GalliaPharm [2020-12-21]
Summary Basis of Decision (SBD) for Pfizer-BioNTech COVID-19 Vaccine [2020-12-21]
Summary Basis of Decision (SBD) for Reblozyl [2020-12-21]
Summary Basis of Decision (SBD) for Sarclisa [2020-12-21]
Adverse reactions, medical device incidents and health product recalls in Canada: 2019 summary report [2020-12-11]
Updated Register of Certificates of Supplementary Protection and Applications [2020-12-10]
Updated Register of Certificates of Supplementary Protection and Applications [2020-12-04]
Updated Register of Certificates of Supplementary Protection and Applications [2020-12-02]

November

TPD/BRDD/NNHPD Drug Submission Quarterly Report for January - September 2020 [2020-11-30]
Interim Order Respecting Drug Shortages (Safeguarding the Drug Supply): Notice [2020-11-28]
Interim Order Respecting Drug Shortages (Safeguarding the Drug Supply) [2020-11-28]
Updated List of Drugs for an Urgent Public Health Need [2020-11-23]
Updated Register of Certificates of Supplementary Protection and Applications [2020-11-16]
Updated Register of Certificates of Supplementary Protection and Applications [2020-11-10]
Guidance document: Product Monograph [2020-11-01]
Product Monograph master template [2020-11-01]
Product Monographs: Frequently asked questions [2020-11-01]

October

Summary Basis of Decision (SBD) for Polivy [2020-10-30]
Updated Register of Certificates of Supplementary Protection and Applications [2020-10-28]
Updated Register of Certificates of Supplementary Protection and Applications [2020-10-20]
Updated Register of Certificates of Supplementary Protection and Applications [2020-10-07]
Summary Basis of Decision (SBD) for Enspryng [2020-10-02]
Summary Basis of Decision (SBD) for Riximyo [2020-10-02]

September

Updated Register of Certificates of Supplementary Protection and Applications [2020-09-24]
Summary Basis of Decision (SBD) for Enspryng [2020-09-24]
Summary Basis of Decision (SBD) for Riximyo [2020-09-24]
Updated Register of Certificates of Supplementary Protection and Applications [2020-09-14]

August

Updated List of Drugs for an Urgent Public Health Need [2020-08-26]
Summary Basis of Decision (SBD) for Beovu [2020-08-25]
Summary Basis of Decision (SBD) for Nivestym [2020-08-25]
Summary Basis of Decision (SBD) for Ruxience [2020-08-25]
Summary Basis of Decision (SBD) for Ziextenzo [2020-08-25]
Updated Register of Certificates of Supplementary Protection and Applications [2020-08-24]
Nitrosamine impurities in medications [2020-08-24]
Order to extend review period for clinical trial applications and amendments: Notice [2020-08-14]
Summary Basis of Decision (SBD) for Daurismo [2020-08-11]
Summary Basis of Decision (SBD) for Mylotarg [2020-08-11]
Summary Basis of Decision (SBD) for Rozlytrek [2020-08-11]
Statement on the classification of insulin products and duration of action: Notice to stakeholders [2020-08-06]
Updated Register of Certificates of Supplementary Protection and Applications [2020-08-05]

July

TPD/BRDD/NNHPD Annual Drug Submission Performance report - Fiscal Year 2019-2020 [2020-07-28]
Updated Register of Certificates of Supplementary Protection and Applications [2020-07-21]
Summary Basis of Decision (SBD) for Ajovy [2020-07-14]
Summary Basis of Decision (SBD) for Kanjinti [2020-07-14]
Mid-year update: Drugs and medical devices approved in 2020 [2020-07-08]

June

Summary Basis of Decision (SBD) for Ajovy [2020-06-30]
Summary Basis of Decision (SBD) for Kanjinti [2020-06-30]
Updated Register of Certificates of Supplementary Protection and Applications [2020-06-23]
Summary Basis of Decision (SBD) for Avsola [2020-06-19]
Summary Basis of Decision (SBD) for Cablivi [2020-06-19]
Updated Register of Certificates of Supplementary Protection and Applications [2020-06-18]

May

Updated Register of Certificates of Supplementary Protection and Applications [2020-05-29]
Drug and medical device highlights 2019: Helping you maintain and improve your health [2020-05-28]
Updated Register of Certificates of Supplementary Protection and Applications [2020-05-25]
Summary Basis of Decision (SBD) for Herzuma [2020-05-22]
Summary Basis of Decision (SBD) for Osnuvo [2020-05-22]
Updated Register of Certificates of Supplementary Protection and Applications [2020-05-12]

April

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]
Updated Register of Certificates of Supplementary Protection and Applications [2020-04-21]
Summary Basis of Decision (SBD) for Galli Eo [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]
DPD Extracts [2020-04-01]
Updated List of Drugs for an Urgent Public Health Need [2020-04-01]

March

February

Updated Register of Certificates of Supplementary Protection and Applications [2020-02-17]
Updated Register of Certificates of Supplementary Protection and Applications [2020-02-10]

January

Updated Register of Certificates of Supplementary Protection and Applications [2020-01-29]
Summary Basis of Decision - Emgality [2020-01-28]
Notice: Product Monograph Implementation Plans [2020-01-13]
Updated Register of Certificates of Supplementary Protection and Applications [2020-01-10]
Summary Basis of Decision - Esperoct [2020-01-06]

2019

December

Updated List of Drugs for an Urgent Public Health Need [2019-12-23]
TPD, BGTD and NNHPD Quarterly Drug Submission Performance Report for Q2-2019-2020 [2019-12-20]
Updated Register of Certificates of Supplementary Protection and Applications [2019-12-13]
Updated Register of Certificates of Supplementary Protection and Applications [2019-12-10]
Summary Basis of Decision - Evenity [2019-12-10]
Summary Basis of Decision - Zirabev [2019-12-10]

November

Updated List of Drugs for an Urgent Public Health Need [2019-11-21]
Summary Basis of Decision - Ogivri [2019-11-15]
Summary Basis of Decision - Skyrizi [2019-11-15]
Updated List of Drugs for an Urgent Public Health Need [2019-11-06]

October

Updated List of Drugs for an Urgent Public Health Need [2019-10-30]
Updated Register of Certificates of Supplementary Protection and Applications [2019-10-29]
Updated Register of Certificates of Supplementary Protection and Applications [2019-10-24]
Updated Register of Certificates of Supplementary Protection and Applications [2019-10-01]

September

Qualifying Notice for Tecentriq [2019-09-30]
Qualifying Notice for Keytruda [2019-09-30]
Updated List of Drugs for an Urgent Public Health Need [2019-09-25]
Updated List of Drugs for an Urgent Public Health Need [2019-09-18]
Updated List of Drugs for an Urgent Public Health Need [2019-09-13]
Updated Register of Certificates of Supplementary Protection and Applications [2019-09-12]
Summary Basis of Decision (SBD) for Libtayo [2019-09-10]
Summary Basis of Decision (SBD) for Yescarta [2019-09-10]
Updated List of Drugs for an Urgent Public Health Need [2019-09-09]
TPD, BGTD and NNHPD Quarterly Drug Submission Performance Report for Q1-2019-2020 [2019-09-04]

August

Updated Register of Certificates of Supplementary Protection and Applications [2019-08-27]
Summary Basis of Decision (SBD) for OXERVATE [2019-08-27]
Summary Basis of Decision (SBD) for TRUXIMA [2019-08-27]
Updated Register of Certificates of Supplementary Protection and Applications [2019-08-19]
Updated List of Drugs for an Urgent Public Health Need [2019-08-15]
Updated Register of Certificates of Supplementary Protection and Applications [2019-08-14]
TPD, BGTD and NNHPD Quarterly Drug Submission Performance Report for Q1-2019-2020 [2019-08-13]

July

Release of the revised Post-Notice of Compliance (NOC) Changes - Quality Guidance [2019-07-31]
Updated Register of Certificates of Supplementary Protection and Applications [2019-07-12]
Summary Basis of Decision (SBD) for BIOTHRAX [2019-07-10]
Summary Basis of Decision (SBD) for VONVENDI [2019-07-10]
Updated Register of Certificates of Supplementary Protection and Applications [2019-07-02]

June

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]
Mandatory reporting requirements for hospitals [2019-06-26]
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]
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]
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]

May

Updated Register of Certificates of Supplementary Protection and Applications [2019-05-31]
Updated List of Drugs for an Urgent Public Health Need [2019-05-28]
Summary Basis of Decision (SBD) for Crysvita [2019-05-24]
Summary Basis of Decision (SBD) for Unituxin [2019-05-24]
Updated Register of Certificates of Supplementary Protection and Applications [2019-05-21]
Health Canada Policy Position Paper - Autologous Cell Therapy Products [2019-05-15]
Regulatory Decision Summary for Modification of MSM Blood Donor Deferral [2019-05-07]
Updated Register of Certificates of Supplementary Protection and Applications [2019-05-03]

April

Updated List of Drugs for an Urgent Public Health Need [2019-05-03]
Updated List of Drugs for an Urgent Public Health Need [2019-04-30]
Updated Register of Certificates of Supplementary Protection and Applications [2019-04-16]
Updated Register of Certificates of Supplementary Protection and Applications [2019-04-08]
Updated Register of Certificates of Supplementary Protection and Applications [2019-04-04]
Updated List of Drugs for an Urgent Public Health Need [2019-04-03]

March

Updated List of Drugs for an Urgent Public Health Need [2019-03-27]
Updated Register of Certificates of Supplementary Protection and Applications[2019-03-11]
Updated Register of Certificates of Supplementary Protection and Applications[2019-03-05]

February

Updated Register of Certificates of Supplementary Protection and Applications [2019-02-27]
BGTD Quarterly Drug Submission Performance report for October - December 2018 [2019-02-25]
Regulatory Decision Summary for ERELZI [2019-02-25]
Summary Basis of Decision (SBD) for HEMLIBRA [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]
Updated Register of Certificates of Supplementary Protection and Applications [2019-02-22]
Notice to Stakeholders - Policy Statement on the Naming of Biologic Drugs [2019-02-14]
What We Heard Report - Stakeholder Consultation on the Naming of Biologic Drugs [2019-02-14]
Updated Register of Certificates of Supplementary Protection and Applications [2019-02-14]
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 Bexsero [2019-02-11]
Post-Authorization Activity Table (PAAT) for Cosentyx [2019-02-11]
Updated Register of Certificates of Supplementary Protection and Applications [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 Grastofil [2019-02-05]

January

Updated Register of Certificates of Supplementary Protection and Applications [2019-01-31]
Updated Register of Certificates of Supplementary Protection and Applications [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 BIOTHRAX [2019-01-24]
Regulatory Decision Summary for DARZALEX [2019-01-24]
Regulatory Decision Summary for TAKHZYRO [2019-01-24]
Post-Authorization Activity Table (PAAT) for Zonovate [2019-01-24]
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]
Post-Authorization Activity Table (PAAT) for Plegridy [2019-01-17]
Post-Authorization Activity Table (PAAT) for Shingrix [2019-01-17]
Post-Authorization Activity Table (PAAT) for Strensiq [2019-01-17]
Post-Authorization Activity Table (PAAT) for Sylvant [2019-01-17]
Post-Authorization Activity Table (PAAT) for Tecentriq [2019-01-17]
Post-Authorization Activity Table (PAAT) for Xofigo [2019-01-17]
Updated Register of Certificates of Supplementary Protection and Applications [2019-01-16]
Summary Basis of Decision (SBD) for Hemlibra [2019-01-14]
Post-Authorization Activity Table (PAAT) for Idelvion [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]
Regulatory Decision Summary for Perjeta [2019-01-14]
Updated List of Drugs for an Urgent Public Health Need [2019-01-11]
Post-Authorization Activity Table (PAAT) for Afstyla [2019-01-10]
Regulatory Decision Summary for Brineura [2019-01-10]
Regulatory Decision Summary for Crysvita [2019-01-10]
Post-Authorization Activity Table (PAAT) for Elelyso [2019-01-10]
Post-Authorization Activity Table (PAAT) for Empliciti [2019-01-10]
Updated Register of Certificates of Supplementary Protection and Applications [2019-01-10]

Page details

Date modified:: 2024-11-25