What's new: Biologics, radiopharmaceuticals and genetic therapies
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.
Subscribe
COVID-19
- 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]
2021
June
- 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
- Qualifying Notice for Enhertu [2021-04-30]
- 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]
- Qualifying Notice for Polivy [2020-10-07]
- 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
- 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]
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]
Report a problem or mistake on this page
- Date modified: