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.
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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.
COVID-19
September 2020
- 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]
August 2020
- Order to extend review period for clinical trial applications and amendments: Notice [2020-08-14]
- Good Manufacturing Practices and COVID-19 [2020-08-07]
- Drug establishment licences and COVID-19 [2020-08-07]
July 2020
- Notice: Prescription Drug List (PDL): Remdesivir (COVID-19) [2020-07-28]
- Regulatory Decision Summary for Veklury (remdesivir) [2020-07-28]
- 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]
June 2020
May 2020
- 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]
- Australia, Canada, Singapore, Switzerland Consortium regulators pledge support to tackle COVID-19 [2020-05-05]
April 2020
- 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]
- Health Product Advertising Incidents related to COVID-19 [2020-04-16]
- 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]
- Drugs and vaccines for COVID-19: Overview [2020-04-03]
- COVID-19 health product industry [2020-04-01]
2020
September
- Register of Innovative Drugs [2020-09-25]
- 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]
- Summary Basis of Decision (SBD) for Ibsrela [2020-09-24]
- Summary Basis of Decision (SBD) for Piqray [2020-09-24]
- Notice: Validation rules for regulatory transactions provided to Health Canada in the "non-eCTD electronic-only" format [2020-09-21]
- Notice - Validation rules for regulatory transactions submitted to Health Canada in the electronic Common Technical Document (eCTD) format [2020-09-21]
- Consultation: Release of Draft (Step 2) ICH Guidance: E14/S7B: Questions & Answers: Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential [2020-09-21]
- Submissions Under Review [2020-09-21]
- Generic Submissions Under Review [2020-09-21]
- Notice to Stakeholders – Clarification of Requirements under the Food and Drug Regulations when Conducting Clinical Research with Cannabis [2020-09-18]
- Notice of Compliance (NOC) Data Extracts [2020-09-18]
- Product Monograph Brand Safety Updates - August 2020 [2020-09-16]
- Updated Register of Certificates of Supplementary Protection and Applications [2020-09-14]
- Register of Innovative Drugs [2020-09-11]
- Notice: Prescription Drug List (PDL): Multiple additions [2020-09-08]
- Notice of Compliance (NOC) Data Extracts [2020-09-04]
- Statistical Report 2019/2020 for the Patented Medicines (Notice of Compliance) Regulations, Data Protection and Certificates of Supplementary Protection [2020-09-02]
August
- DPD Extracts [2020-09-01]
- Notice - Release of ICH M9: Biopharmaceutics Classification System (BCS) Based Biowaivers [2020-08-26]
- Notice - Release of ICH M9 Questions & Answers: Biopharmaceutics Classification System (BCS) Based Biowaivers [2020-08-26]
- 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 Odomzo [2020-08-25]
- Summary Basis of Decision (SBD) for Ruxience [2020-08-25]
- Summary Basis of Decision (SBD) for Veklury [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]
- Notice of Compliance (NOC) Data Extracts [2020-08-21]
- Notice - Prescription Drug List: Vitamin D [2020-08-19]
- Generic Submissions Under Review [2020-08-19]
- Submission Under Review [2020-08-19]
- Register of Innovative Drugs [2020-08-18]
- Notice - Release of ICH S11: Nonclinical Safety Testing in Support of Development of Paediatric Medicines [2020-08-17]
- Product Monograph Brand Safety Updates - July 2020 [2020-08-12]
- 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]
- Notice - Release of ICH S5(R3): Detection of Toxicity to Reproduction for Medicinal Products & Toxicity to Male Fertility [2020-08-10]
- Notice of Compliance (NOC) Data Extracts [2020-08-07]
- 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]
- DPD Extracts [2020-08-04]
July
- Notice of Compliance (NOC) Data Extracts [2020-07-31]
- Register of Innovative Drugs [2020-07-29]
- TPD/BRDD/NNHPD Annual Drug Submission Performance report - Fiscal Year 2019-2020 [2020-07-28]
- Submission Under Review [2020-07-28]
- Notice of Compliance (NOC) Data Extracts [2020-07-27]
- Register of Innovative Drugs [2020-07-24]
- Submission Under Review [2020-07-24]
- Generic Submissions Under Review [2020-07-23]
- Notice - Release of ICH E9(R1): Defining the Appropriate Estimand for a Clinical Trial/ Sensitivity Analyses [2020-07-21]
- Updated Register of Certificates of Supplementary Protection and Applications [2020-07-21]
- Register of Innovative Drugs [2020-07-17]
- Summary Basis of Decision (SBD) for Ajovy [2020-07-14]
- Summary Basis of Decision (SBD) for Kanjinti [2020-07-14]
- Summary Basis of Decision (SBD) for Nubeqa [2020-07-14]
- Summary Basis of Decision (SBD) for Vocabria/Cabenuva [2020-07-14]
- Register of Innovative Drugs [2020-07-13]
- Notice of Compliance (NOC) Data Extracts [2020-07-10]
- Notice: Prescription Drug List (PDL): Multiple additions [2020-07-10]
- Product Monograph Brand Safety Updates - June 2020 [2020-07-10]
- Release of draft (step 2) ICH guidance: M7(R2): Assessment and Control of DNA Reactive (mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk [2020-07-07]
- Mid-year update: Drugs and medical devices approved in 2020 [2020-07-08]
- Notice - Confirmation of the Mandatory use of the Regulatory Enrolment Process (REP) as of October 1, 2020 [2020-07-06]
- DPD Extracts [2020-07-02]
June
- Release of draft (Step 2) ICH guidance: Q3C(R8): Impurities: Residual solvents [2020-06-30]
- Summary Basis of Decision (SBD) for Ajovy [2020-06-30]
- Summary Basis of Decision (SBD) for Kanjinti [2020-06-30]
- Summary Basis of Decision (SBD) for Vocabria/Cabenuva [2020-06-30]
- Register of Innovative Drugs [2020-06-29]
- Notice of Compliance (NOC) Data Extracts [2020-06-26]
- Updated Register of Certificates of Supplementary Protection and Applications [2020-06-23]
- Generic Submissions Under Review [2020-06-23]
- Submissions Under Review [2020-06-23]
- Register of Innovative Drugs [2020-06-19]
- Summary Basis of Decision (SBD) for Avsola [2020-06-19]
- Summary Basis of Decision (SBD) for Cablivi [2020-06-19]
- Summary Basis of Decision (SBD) for Vyndaqel [2020-06-19]
- Updated Register of Certificates of Supplementary Protection and Applications [2020-06-18]
- Register of Innovative Drugs [2020-06-15]
- Notice of Compliance (NOC) Data Extracts [2020-06-12]
- Product Monograph Brand Safety Updates - May 2020 [2020-06-11]
- Register of Innovative Drugs [2020-06-05]
- Tecentriq: Qualifying Notice Amendment [2020-06-02]
- DPD Extracts [2020-06-01]
May
- Updated Register of Certificates of Supplementary Protection and Applications [2020-05-29]
- Notice of Compliance (NOC) Data Extracts [2020-05-29]
- Drug and medical device highlights 2019: Helping you maintain and improve your health [2020-05-28]
- Notice: Expansion of the medical device Regulatory Enrolment Process (REP) pilot and the scope for transactions sent via the Common Electronic Submissions Gateway (CESG) [2020-05-26]
- 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 Mayzent [2020-05-22]
- Summary Basis of Decision (SBD) for Osnuvo [2020-05-22]
- Summary Basis of Decision (SBD) for Rinvoq [2020-05-22]
- Summary Basis of Decision (SBD) for Vascepa [2020-05-22]
- Summary Basis of Decision (SBD) for Xofluza [2020-05-22]
- Notice of Compliance (NOC) Data Extracts [2020-05-15]
- Submissions Under Review [2020-05-14]
- Generic Submissions Under Review [2020-05-14]
- Updated Register of Certificates of Supplementary Protection and Applications [2020-05-12]
- Product Monograph Brand Safety Updates - April 2020 [2020-05-12]
- Register of Innovative Drugs [2020-05-08]
- DPD Extracts [2020-05-01]
- Register of Innovative Drugs [2020-05-01]
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]
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]
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 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]
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
- Notice of Compliance with Conditions - Qualifying Notice for Blincyto [2019-12-31]
- Notice of Compliance (NOC) Data Extracts [2019-12-30]
- Updated List of Drugs for an Urgent Public Health Need [2019-12-23]
- Notice of Compliance (NOC) Data Extracts [2019-12-20]
- Register of Innovative Drugs [2019-12-20]
- TPD, BGTD and NNHPD Quarterly Drug Submission Performance Report for Q2-2019-2020 [2019-12-20]
- Product Monograph Brand Safety Updates - November 2019 [2019-12-20]
- Updated Register of Certificates of Supplementary Protection and Applications [2019-12-13]
- Generic Submissions Under Review [2019-12-13]
- Notice of Compliance (NOC) Data Extracts [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 - Zejula [2019-12-10]
- Summary Basis of Decision - Zirabev [2019-12-10]
- Post-Authorization Activity Table (PAAT) - Biktarvy [2019-12-10]
- Post-Authorization Activity Table (PAAT) - Blexten [2019-12-10]
- Post-Authorization Activity Table (PAAT) - Bystolic [2019-12-10]
- Post-Authorization Activity Table (PAAT) - Erleada [2019-12-10]
- Notice of Compliance (NOC) Data Extracts [2019-12-06]
- Register of Innovative Drugs [2019-12-06]
- Final Record of Decisions June 5, 2018 Meeting: Canadian Generic Pharmaceutical Association (CGPA) [2019-12-04]
- Final Record of Decisions December 4, 2018 Meeting: Canadian Generic Pharmaceutical Association (CGPA) [2019-12-04]
- Final Record of Decisions October 2, 2018 Meeting: Groupement provincial de l'industrie du médicament (GPIM) [2019-12-04]
- Final Record of Decisions May 10, 2018 Meeting: Innovative Medicines Canada (IMC) [2019-12-04]
- Final Record of Decisions November 13, 2018 Meeting: Innovative Medicines Canada (IMC) [2019-12-04]
- Final Record of Decisions May 24, 2018 Meeting: Canada's Medical Technology Companies (MEDEC) [2019-12-04]
- Final Record of Decisions November 8, 2018 Meeting: Canada's Medical Technology Companies (MEDEC) [2019-12-04]
- Generic Submissions Under Review [2019-12-03]
- Submissions Under Review [2019-12-03]
- DPD Extracts [2019-12-02]
November
- Notice: Prescription Drug List (PDL): Multiple additions [2019-11-29]
- Notice - Submitting Master File Transactions via the Common Electronic Submissions Gateway (CEGS) [2019-11-29]
- Notice - Update to Clinical Trial Site Information Form [2019-11-29]
- Notice of Compliance (NOC) Data Extracts [2019-11-29]
- Notice of Compliance (NOC) Data Extracts [2019-11-22]
- Updated List of Drugs for an Urgent Public Health Need [2019-11-21]
- Notice of Compliance with Conditions - Qualifying Notice for Balversa [2019-11-18]
- Notice of Compliance with Conditions - Qualifying Notice for Bavencio [2019-11-15]
- Notice of Compliance (NOC) Data Extracts [2019-11-15]
- Register of Innovative Drugs [2019-11-15]
- Summary Basis of Decision - Ogivri [2019-11-15]
- Summary Basis of Decision - Onpattro [2019-11-15]
- Summary Basis of Decision - Skyrizi [2019-11-15]
- Summary Basis of Decision - Verzenio [2019-11-15]
- Summary Basis of Decision - Vizimpro [2019-11-15]
- Product Monograph Brand Safety Updates - October 2019 [2019-11-15]
- Notice of Compliance (NOC) Data Extracts [2019-11-08]
- Updated List of Drugs for an Urgent Public Health Need [2019-11-06]
- DPD Extracts [2019-11-01]
- Register of Innovative Drugs [2019-11-01]
- Notice of Compliance (NOC) Data Extracts [2019-11-01]
October
- Updated List of Drugs for an Urgent Public Health Need [2019-10-30]
- Submissions Under Review [2019-10-30]
- Generic Submissions Under Review [2019-10-30]
- Updated Register of Certificates of Supplementary Protection and Applications [2019-10-29]
- Notice of Compliance (NOC) Data Extracts [2019-10-25]
- Updated Register of Certificates of Supplementary Protection and Applications [2019-10-24]
- Register of Innovative Drugs [2019-10-21]
- Register of Innovative Drugs [2019-10-18]
- Notice of Compliance (NOC) Data Extracts [2019-10-18]
- Product Monograph Brand Safety Updates - September 2019 [2019-10-16]
- Notice of Compliance (NOC) Data Extracts [2019-10-11]
- Register of Innovative Drugs [2019-10-10]
- Notice of Compliance with Conditions - Qualifying Notice for Lenvima [2019-10-09]
- Notice: Prescription Drug List (PDL): Multiple additions [2019-10-07]
- Register of Innovative Drugs [2019-10-04]
- DPD Extracts [2019-10-04]
- Notice of Compliance (NOC) Data Extracts [2019-10-04]
- Updated Register of Certificates of Supplementary Protection and Applications [2019-10-01]
- DPD Extracts [2019-10-01]
September
- Notice of Compliance (NOC) Data Extracts [2019-09-27]
- Updated List of Drugs for an Urgent Public Health Need [2019-09-25]
- Notice of Compliance (NOC) Data Extracts [2019-09-20]
- Register of Innovative Drugs [2019-09-20]
- Updated List of Drugs for an Urgent Public Health Need [2019-09-18]
- Submissions Under Review [2019-09-16]
- Generic Submissions Under Review [2019-09-16]
- Notice of Compliance (NOC) Data Extracts [2019-09-13]
- Updated notice: Mandatory Use of the Electronic Common Technical Guidance (eCTD) Format [2019-09-13]
- 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 Idhifa [2019-09-10]
- 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]
- Product Monograph Brand Safety Updates - August 2019 [2019-09-09]
- Register of Innovative Drugs [2019-09-06]
- Notice of Compliance (NOC) Data Extracts [2019-09-06]
- TPD, BGTD and NNHPD Quarterly Drug Submission Performance Report for Q1-2019-2020 [2019-09-04]
- DPD Extracts [2019-09-04]
August
- Register of Innovative Drugs [2019-08-30]
- Notice of Compliance (NOC) Data Extracts [2019-08-30]
- Register of Innovative Drugs [2019-08-29]
- The Regulatory Enrolment Process (REP) is now in production. All regulatory transactions for human drugs, pursuant to Division 1 and 8 of the Food and Drug Regulations are encouraged use REP with regulatory transactions prepared in both eCTD and non-eCTD formats. The REP information page has been updated to include the REP Guidance Document, REP templates as well as information on REP pilots coming up for Veterinary Drugs and Clinical Trials. [2019-08-28]
- Blincyto - Notice of Compliance with Conditions - Qualifying Notice [2019-08-28]
- Updated Register of Certificates of Supplementary Protection and Applications [2019-08-27]
- Biosimilar biologic drugs in Canada: Fact Sheet [2019-08-27]
- Summary Basis of Decision (SBD) for LORBRENA [2019-08-27]
- Summary Basis of Decision (SBD) for ONSTRYV [2019-08-27]
- Summary Basis of Decision (SBD) for OXERVATE [2019-08-27]
- Summary Basis of Decision (SBD) for TRUXIMA [2019-08-27]
- Health Canada approves updates to Mifegymiso prescribing information: Ultrasound no longer mandatory [2019-08-23]
- Submissions Under Review [2019-08-20]
- Biopharmaceutics Classification System (BCS) based biowaiver evaluation template [2019-08-23]
- Notice of Compliance (NOC) Data Extracts [2019-08-23]
- Generic Submissions Under Review [2019-08-23]
- Updated Register of Certificates of Supplementary Protection and Applications [2019-08-19]
- Notice of Compliance (NOC) Data Extracts [2019-08-16]
- 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]
- Master File (MF) Application Fee Form for Human Drugs [2019-08-14]
- Product Monograph Brand Safety Updates - July 2019 [2019-08-13]
- Radiopharmaceuticals, Kits, and Generators: Submission Information for Schedule C Drugs - Guidance document [2019-08-13]
- TPD, BGTD and NNHPD Quarterly Drug Submission Performance Report for Q1-2019-2020 [2019-08-13]
- Release of the revised Guidance Document: Post-Notice of Compliance (NOC) Changes - Safety and Efficacy [2019-08-12]
- Notice of Consultation on the Prescription Drug List (PDL): Epinephrine chloride (topical solution) [2019-08-12]
- Register of Innovative Drugs [2019-08-12]
- Notice of Compliance (NOC) Data Extracts [2019-08-09]
- Revisions to the Guidance Document: Questions & Answers: Plain Language Labelling Regulations for Prescription Drugs [2019-08-08]
- Register of Innovative Drugs [2019-08-06]
- 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 Update [2019-08-06]
- Notice of Compliance (NOC) Data Extracts [2019-08-02]
- DPD Extracts [2019-08-01]
July
- Release of the revised Post-Notice of Compliance (NOC) Changes - Quality Guidance [2019-07-31]
- Release of the revised Notice regarding the Post-Notice of Compliance (NOC) Changes- Notices of Change: Level III Form [2019-07-31]
- Register of Innovative Drugs [2019-07-26]
- Notice of Compliance (NOC) Data Extracts [2019-07-26]
- Revisions to the Guidance Document: Management of Drug Submissions and Applications [2019-07-25]
- Labels and Packages Certification Form for Prescription Products [2019-07-25]
- Generic Submissions Under Review [2019-07-22]
- Submissions Under Review [2019-07-22]
- ICH Global Meeting on ICH E8(R1) Guideline on General Considerations for Clinical Trials [2019-07-19]
- Notice of Compliance (NOC) Data Extracts [2019-07-19]
- Agile regulations for advanced therapeutic products and clinical trials [2019-07-18]
- Organisation and Document Placement for Canadian Module 1 of the Common Technical Document (CTD) Structure [2019-07-17]
- 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]
- Enabling advanced therapeutic products and modernizing the regulation of clinical trials [2019-07-02]
- 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]
- 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 Format for Product Monographs [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 - 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
- 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]
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