Drug product announcements
COVID-19
December 2023
- 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]
- Authorization of Novavax Nuvaxovid COVID-19 vaccine for the Omicron XBB.1.5 subvariant [2023-12-05]
September 2023
- 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]
July 2023
May 2023
- Authorization of Moderna Spikevax Bivalent (BA.4/5) COVID-19 vaccine booster for 6 to 17 year olds [2023-05-18]
February 2023
- Authorization of Moderna Spikevax Bivalent (BA.1) COVID-19 vaccine booster for 6 to 17 year olds [2023-02-17]
January 2023
- 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]
December 2022
- 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]
November 2022
- 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]
October 2022
- 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]
September 2022
- 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]
August 2022
- 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]
July 2022
- Authorization of Moderna Spikevax COVID-19 vaccine for children ages 6 months to 5 years [2022-07-14]
April 2022
- Blood safety in Canada: Restriction lifted for men who have sex with men [2022-04-28]
- Remdesivir approved for treating COVID-19 in an outpatient setting [2022-04-22]
- Evusheld COVID-19 treatment [2022-04-14]
- Updated: Special Access Program for drugs: Guidance document for industry and practitioners [2022-04-11]
March 2022
- 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]
February 2022
- Medicago Covifenz COVID-19 vaccine [2022-02-24]
- Novavax Nuvaxovid COVID-19 vaccine [2022-02-17]
January 2022
November 2021
- What we heard report: Records retention consultations related to the clinical trials interim order transition regulations [2021-11-19]
- Authorization of Pfizer-BioNTech Comirnaty COVID-19 vaccine for children ages 5-11 [2021-11-19]
October 2021
September 2021
- Regulations amending certain regulations concerning drugs and medical devices (shortages): Notice [2021-09-01]
May 2021
- 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]
April 2021
March 2021
- 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]
- 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]
February 2021
- AstraZeneca COVID-19 vaccine [2021-02-26]
January 2021
- Regulatory innovation for health products [2021-01-29]
- Statement about confidence in COVID-19 vaccines for health care professionals [2021-01-20]
- Adverse Events Following Immunization Report [2020-01-08]
- Summary Basis of Decision (SBD) for the Moderna COVID-19 Vaccine [2021-01-06]
December 2020
- Moderna COVID-19 vaccine [2020-12-23]
- Bamlanivimab [2020-12-22]
- Ensuring predictability for COVID-19 clinical trials and proposal for clinical trials records retention: Notice to stakeholders [2020-12-10]
- 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]
- Remdesivir (Veklury) [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]
November 2020
- Statement from Global Medicines Regulators on the Value of Regulatory Reliance [2020-11-27]
- Update on remdesivir: continued monitoring [2020-11-26]
- Ensuring predictability for interim orders relating to COVID-19: Notice to stakeholders [2020-11-23]
- Guidance for market authorization requirements for COVID-19 vaccines [2020-11-21]
- Notice Prescription Drug List (PDL): Bamlanivimab (COVID-19) [2020-11-20]
October 2020
- 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]
- Health Canada's special access programs [2020-10-14]
- Notice to stakeholders: Final guidance document for industry and practitioners on the Special Access Program (SAP) for drugs [2020-10-14]
- Public release of clinical information for drugs and medical devices in COVID-19 interim orders applications: Guidance [2020-10-07]
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
- Good Manufacturing Practices and COVID-19 [2020-08-07]
- Drug establishment licences and COVID-19 [2020-08-07]
July 2020
- 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]
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]
- 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]
Other drug product announcements
2024
- Drug shortages in Canada: Fiscal year 2023 to 2024 in review [2024-11-20]
- Change in filing requirements for the extensible markup language product monograph (XML PM): Notice [2024-11-18]
- Updated: Notice to industry: Aligned reviews between Health Canada and health technology assessment organizations [2024-11-05]
- Consultation on draft National Priority List of Pediatric Drugs [2024-10-21]
- Updated: Master File Application Form [2024-10-09]
- Notice: Publication of the Guidance Document: Certificates of Supplementary Protection [2024-08-19]
- Notice - Release of the final guidance document: “Switching from prescription to non-prescription status” [2024-08-14]
- 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]
- Updated: Guidance Document: Regulatory requirements for Drug Identification Numbers (DINs) [2024-07-15]
- Building resilience: Health Canada’s plan to address health product shortages, 2024 to 2028 [2024-06-25]
- Nitrosamine impurities in medications: Recalls [2024-06-19]
- Mandatory reporting by hospitals of serious adverse drug reactions related to biocides - Notice [2024-06-19]
- Updated: Master File Application Form [2024-06-17]
- 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: Guidance Document - Preparation of Regulatory Activities in Non-eCTD Format [2024-05-13]
- Updated: Guidance Document: Regulatory requirements for Drug Identification Numbers (DINs) [2024-05-01]
- Organization and document placement for Canadian module 1 [2024-04-23]
- Memorandum of Understanding between the Competition Bureau and Health Canada [2024-03-07]
- 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]
- Notice: Expansion of the Generic Submissions Under Review List [2024-02-23]
- Pilot on pediatric development plans and studies [2024-02-07]
- Notice: Posting information in the Drug Product Database online [2024-02-02]
- Updated: Validation rules for regulatory transactions filed in eCTD format [2024-01-30]
- Updated: Validation rules for regulatory transactions filed in non-eCTD format [2024-01-30]
- Notice: Application of the definition of Canadian Reference Product [2024-01-26]
- Updated: Master file application form [2024-01-02]
- Update to the Guidance Document: Master Files (MFs) - Procedures and Administrative Requirements [2024-01-02]
2023
- Updated: Guidance Document - Certificates of Supplementary Protection [2023-12-20]
- Notice: Release of revised notice for (Step 4) ICH S1B(R1): Testing for Carcinogenicity of Pharmaceuticals [2023-12-01]
- Updated: Validation Rules for regulatory transactions filed in eCTD format [2023-11-20]
- Updated: Validation Rules for regulatory transactions filed in non-eCTD format [2023-11-20]
- Notice: Publication of the Guidance Document: Certificates of Supplementary Protection [2023-11-16]
- Classifying pheromone-based products for companion animals: Notice to stakeholders [2023-11-03]
- Updated: Guidance on nitrosamine impurities in medications [2023-10-20]
- Notice: Release of (Step 4) ICH M7(R2) Guideline, Addendum, Q&As - Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk [2023-09-29]
- Updated Master file application form [2023-09-21]
- Consultation on the changes to the 2020 product monograph guidance and master template [2023-09-15]
- Post-Notice of Compliance (NOC) Changes: Guidance for quality of veterinary drugs [2023-08-28]
- Notice: Release of (Step 4) ICH S12 Guideline - Nonclinical Biodistribution Considerations for Gene Therapy Products[2023-07-21]
- Updated Master File Application Form [2023-07-19]
- Consultation: Proposal to amend the list of maximum residue limits for veterinary drugs in foods - Proposed MRL 2023-1 [2023-07-11]
- Consultation on draft guidance on submitting pediatric studies for drugs [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]
- Update: Guidance document: preparation of regulatory activities in non-eCTD format [2023-06-16]
- Implementing the regulatory enrolment process (REP) for medical devices regulatory activities: Notice [2023-06-15]
- Veterinary drugs master file updates and fees consultation: Notice [2023-06-02]
- Health Canada’s position on the CADTH Guidance for Reporting RWE to Support Decision-making [2023-05-18]
- Notice: Publication of the Guidance Document: Certificates of Supplementary Protection [2023-05-12]
- New Master File Application Form: Notice [2023-05-01]
- Nitrosamine impurities in medications: Guidance [2023-04-17]
- Consultation: Proposed application of the definition of Canadian Reference Product (CRP) [2023-03-27]
- Serious adverse drug reactions and medical device incidents reported by Canadian hospitals [2023-03-23]
- Health Canada changes filing requirements for product monographs: Notice [2023-03-10]
- Notice to stakeholders – Clarification of requirements under the Food and Drug Regulations when conducting clinical trials with cannabis [2023-03-09]
- Consultation period extended until April 26, 2023 for proposed agile regulations and guidance for licensing drugs and medical devices [2023-03-06]
- Notice to stakeholders: Requests to the Special Access Program (SAP) involving psychedelic-assisted psychotherapy [2023-02-27]
- Consultation: Release of Draft (Step 2) ICH guideline, ICH M13 [2023-02-24]
- Consultation: Registration of Clinical Trials and Public Disclosure of Results: Draft Guidance and Public Search Portal [2023-02-23]
- New products for serious adverse drug reaction hospital reporting: Notice [2023-02-15]
- Guidance Document Conduct and Analysis of Comparative Bioavailability Studies [2023-01-30]
- Drug shortages in Canada: Information for consumers [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]
2022
- Consultation on proposed agile regulations and guidance for licensing drugs and medical devices [2022-12-16]
- Veterinary drug experimental studies [2022-12-13]
- Non-prescription Drug Action Plan [2022-12-08]
- Notice to stakeholders: Health Canada's expectations regarding risk-management measures for clinical trials involving psychedelic-assisted psychotherapy [2022-12-05]
- Consultation: Release of Draft (Step 2) ICH M11 guideline, technical specification and template [2022-11-18]
- Consultation: Release of Draft (Step 2) ICH guideline, ICH Q5A(R2) [2022-11-02]
- Infant and children's acetaminophen and ibuprofen shortage [2022-10-26]
- Health Canada to monitor the inclusion of disaggregated data in clinical evidence: Notice to stakeholders [2022-10-03]
- Consultation Extension: Draft (Step 2) ICH Guideline E11A [2022-09-29]
- Updated: Guidance document preparation of regulatory activities in non-eCTD format [2022-09-15]
- Guidance on veterinary drug labelling [2022-09-13]
- Updated: Guidance on nitrosamine impurities in medications [2022-09-01]
- 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]
- Notice: Revision to the Guidance Document Management of Drug Submissions and Applications (August 2022) [2022-08-02]
- Notice: Revisions to the performance standards for Post-authorization Division 1 Changes [2022-08-02]
- Updated: Guidance Document Post-Drug Identification Number (DIN) Changes [2022-08-02]
- Consultation: Release of Draft (Step 2) ICH guideline, ICH M12 [2022-07-29]
- Consultation: Exceptions to the Prescription Drug List [2022-07-28]
- Consultation on Post-Notice of Compliance changes: Draft guidance for quality of veterinary drugs [2022-07-28]
- Notice: Revised guidance documents on Post-Notice of Compliance changes for veterinary drugs [2022-07-28]
- Post-Notice of Compliance changes: Framework document for veterinary drugs [2022-07-28]
- Post-Notice of Compliance changes: Guidance for safety and efficacy of veterinary drugs [2022-07-28]
- Draft ICH guideline Q2(R2): Revision to Analytical Validation [2021-06-13]
- Draft ICH guideline Q14: Analytical Procedure Development [2021-06-13]
- Draft ICH guideline E11A: Paediatric Extrapolation [2021-06-13]
- Notice: Release of Final (Step 4) ICH Q&A Document, ICH E14/S7B: Questions & Answers - Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential [2022-06-10]
- Notice: New products for serious adverse drug reaction hospital reporting [2022-06-01]
- Notice to stakeholders: Considerations regarding the proposed use of psilocybin mushrooms in clinical trials, or as a drug accessed through the Special Access Program (SAP) [2022-05-06]
- Notice: Interim implementation of electronic labelling for human prescription drugs [2022-04-22]
- Comment on the draft revised Guidance document: Switching a medicinal ingredient from prescription to non-prescription status [2022-04-21]
- Keeping Health Products In Canada Safe [2022-04-05]
- Notice: Regulations amending certain regulations concerning drugs and medical devices (shortages) [2022-03-02]
- Updated: Guidance Document - Preparation of Regulatory Activities in Non-eCTD format and Filing Submission Electronically webpage [2022-02-28]
- What we heard report on the clinical trials regulatory modernization initiative [2022-02-23]
- Updated: Guidance Document: Regulatory requirements for Drug Identification Numbers (DINs) [2022-02-10]
- Consultation: Release of Draft ICH : Q9(R1): Quality Risk Management [2022-01-14]
- ICH E8(R1): General Considerations for Clinical Studies [2022-01-14]
- Notice to Stakeholders – Clarification of Requirements under the Food and Drug Regulations and the Controlled Drugs and Substances Act When Conducting Clinical Research with Psilocybin [2022-01-11]
- Joint Notice on Collaboration between the Competition Bureau and Health Products and Food Branch of Health Canada [2022-01-10]
- Guidance Document: Special Access Program for Drugs: Guidance Document for Industry and Practitioners [2022-01-05]
2021
- Notice – Interim Implementation of International Council for Harmonisation (ICH) Q12: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management [2021-11-29]
- Extension: Release of draft revised guidance documents on Post-Notice of Compliance (NOC) Changes - Quality, for stakeholder consultation [2021-11-26]
- Consultation: Release of Draft (Step 2) ICH Guideline: M7(R2): Addendum to the Guideline on Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk [2021-11-12]
- Guide to distributing drugs intended for the Canadian market for consumption or use outside Canada (GUI-145) [2021-11-10]
- Guide on the requirements for providing information related to drug shortages (GUI-146) [2021-11-10]
- Notice: Update on Health Canada's implementation of ICH's Q12 guideline and pilot programs [2021-11-05]
- Consultation: Release of Draft (Step 2) ICH Guidance: Q13: Continuous Manufacturing of Drug Substances and Drug Products [2021-10-28]
- Extension: Release of draft revised guidance documents on Post-Notice of Compliance (NOC) Changes – Quality, for stakeholder consultation [2021-10-15]
- Prescription status of edaravone and personal importation: Notice of update [2021-09-29]
- 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 [2021-08-26]
- The Drug Establishment Licensing Bulletin [2021-08-10]
- Consultation: Release of draft revised guidance documents on Post-Notice of Compliance (NOC) Changes – Quality, for stakeholder consultation [2021-08-06]
- Notice: Release of draft revised guidance documents on Post-Notice of Compliance (NOC) Changes – Quality, for stakeholder consultation [2021-08-06]
- Notice: Clarifications Regarding Access to Restricted Drugs through the Special Access Program (SAP) [2021-07-23]
- Notice: Revision to the Guidance Document: Management of Drug Submissions and Applications [2021-07-07]
- Consultation: Release of Draft (Step 2) ICH Guidance: S12: Nonclinical Biodistribution Considerations for Gene Therapy Products [2021-07-05]
- Consultation: Release of Draft (Step 2) ICH Guidance: S1B(R1): Addendum to the Guideline on Testing for Carcinogenicity of Pharmaceuticals [2021-06-10]
- Notice: Release of ICH Q3C(R8): Maintenance: Impurities: Residual Solvents [2021-06-04]
- Updated: Notice to Stakeholders – Clarification of Requirements Under the Food and Drug Regulations When Conducting Clinical Research With Cannabis [2021-05-31]
- Notice: Phase II of the XML PM Project (Product Monograph in the Extensible Markup Language Format) [2021-05-28]
- 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 [2021-04-16]
- Notice to Stakeholders: Expiration Dating for Medical Gases [2021-03-26]
- Notice: Publication of the Guidance Document: Certificates of Supplementary Protection [2021-01-06]
- Notice to stakeholders: Harmonizing fludeoxyglucose (F-18 FDG) product monographs [2021-01-06]
2020
- Consultation: ICH Reflection Paper: Proposed ICH Guideline Work to Advance Patient-Focused Drug Development [2020-12-16]
- Adverse reactions, medical device incidents and health product recalls in Canada: 2019 summary report [2020-12-11]
- 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]
- Notice: Interim Implementation of International Council for Harmonisation (ICH) Q12: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management [2020-10-09]
- Notice: Health Canada and United States Food and Drug Administration Joint Public Consultation on the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guidelines [2020-10-08]
- Release of Draft (Step 2) ICH Guidance: Q3D(R2): Impurities: Elemental Impurities [2020-09-29]
- 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]
- Notice to Stakeholders - Clarification of Requirements under the Food and Drug Regulations when Conducting Clinical Research with Cannabis [2020-09-18]
- 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]
- Nitrosamine impurities in medications [2020-08-24]
- Notice - Release of ICH S11: Nonclinical Safety Testing in Support of Development of Paediatric Medicines [2020-08-17]
- Order to extend review period for clinical trial applications and amendments: Notice [2020-08-14]
- Notice - Release of ICH S5(R3): Detection of Toxicity to Reproduction for Medicinal Products & Toxicity to Male Fertility [2020-08-10]
- Statement on the classification of insulin products and duration of action: Notice to stakeholders [2020-08-06]
- Notice - Release of ICH E9(R1): Defining the Appropriate Estimand for a Clinical Trial/ Sensitivity Analyses [2020-07-21]
- 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]
- Notice - Confirmation of the Mandatory use of the Regulatory Enrolment Process (REP) as of October 1, 2020 [2020-07-06]
- Release of draft (Step 2) ICH guidance: Q3C(R8): Impurities: Residual solvent [2020-06-30]
- Notice: Expedited Review of Health Product Submissions and Applications to address COVID-19 [2020-03-18]
- Notice - Product Monograph Implementation Plans [2020-01-13]
2019
- Radiopharmaceuticals, Kits, and Generators: Submission Information for Schedule C Drugs - Guidance document [2019-08-13]
- Release of the revised Guidance Document: Post-Notice of Compliance (NOC) Changes - Safety and Efficacy [2019-08-12]
- Revisions to the Guidance Document: Questions & Answers: Plain Language Labelling Regulations for Prescription Drugs [2019-08-08]
- Release of the revised Post-Notice of Compliance (NOC) Changes - Quality Guidance [2019-07-31]
- Revisions to the Guidance Document: Management of Drug Submissions and Applications [2019-07-25]
- Notice: Guidance on the Clinical Assessment of Abuse Liability for Drugs with Central Nervous System Activity [2019-07-08]
- Revisions to the Guidance Document: Administrative Processing of Submissions and Applications Involving Human or Disinfectant Drugs [2019-06-28]
- Notice to Stakeholders: Statement on the Investigational Use of Marketed Drugs in Clinical Trials [2019-06-05]
- 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 Intent - Structured Product Monograph [2019-04-10]
- Notice: Discontinuation of Acknowledgement Letters for Regulatory Activities received by Health Canada [2019-01-30]
- Notice: Release of the Draft Guidance Document: Regulatory Requirements for Drug Identification Numbers (DINs) [2019-01-25]
2018
- Notice - Health Canada's efforts to support innovative human therapeutic products to combat antimicrobial resistance (AMR) [2018-11-15]
- Notice to Stakeholders - Opioid warning sticker and patient information handout requirements come into force on October 23, 2018 [2018-10-01]
- Notice of Amendment: List of Opioids (Part A): Buprenorphine and Methadone [2018-10-01]
- Patient Information - Auvi-Q®(epinephrine injection) Auto-Injector For Allergic Emergencies (Anaphylaxis) [2018-08-29]
- AUVI-Q highlights of prescribing information [to follow]
- Interim Order Respecting Epinephrine Auto-injectors [2018-08-29]
- Explanatory Note - Epinephrine [2018-08-29]
- Notice: Phase III of Pre-Market Transparency Initiatives for Prescription Drugs [2018-08-21]
- Notice: Implications of the Tobacco and Vaping Products Act for Health Products Regulated Under the Food and Drugs Act [2018-07-11]
- Notice: Release of the revised Guidance Document: Post-Notice of Compliance (NOC) Changes - Safety and Efficacy [2018-06-26]
- Notice of Intent to Restrict Marketing and Advertising of Opioids [2018-06-19]
- Notice: Health Canada Review of Vitamin D Levels for Non-Prescription Use [2018-06-04]
- Notice: Revision of Guidance documents: Conduct and Analysis of Comparative Bioavailability Studies & Comparative Bioavailability Standards: Formulations used for Systemic Effects [2018-06-08]
- Updated: Guidance Document: Patented Medicines (Notice of Compliance Regulations [2018-05-11]
- Updated: Patent Register - Frequently Asked Questions [2018-05-11]
- What We Heard- Proposals for prescription drug transparency [2018-04-25]
- Notice - Update on Health Canada's efforts to support innovative human therapeutic products to combat antimicrobial resistance (AMR) and consultation on a proposed Pathogens of Interest List [2018-04-17]
2017
- Amendments to the Food and Drug Regulations for Mica [2017-12-21]
- Notice: Consultation on the Use of a Foreign-sourced Reference Product as a Canadian Reference Product [2017-12-18]
- Updated Register of Certificates of Supplementary Protection and Applications [2017-11-28]
- Publication of the Health Canada Guidance Document: Quality (Chemistry and Manufacturing) Guidance: New Drug Submissions (NDSs) and Abbreviated New Drug Submissions (ANDSs) [2017-10-30]
- Notice: Publication of the Guidance Document: Certificate of Supplementary Protection Regulations [2017-09-19]
- Notice: Validation rules for regulatory transactions provided to Health Canada in the "non-eCTD electronic-only" format [2017-07-28]
- Notice: Publication of Update to the Guidance Document: Data Protection under C.08.004.1 of the Food and Drug Regulations [2017-05-17]
- Notice to Stakeholders: Release of the Product Monograph Template - Schedule D - Biosimilar Biologic Drug [2017-05-15]
- IGDRP/Health Canada/CAPRA Symposium [2017-05-09]
- Notice: Release of the Final Guidance Document: Master Files (MFs) Procedures and Administrative Requirements [2017-04-28]
- Notice - Intellectual Property Hold for Notifiable Change Submissions [2017-04-07]
- Notice: Availability of Summary Basis of Decision Documents and Regulatory Decision Summaries on the Drug and Health Product Register [2017-03-29]
- Notice Upcoming Changes to the Annual Drug Notification Form [2017-03-14]
- Notice: Guidance Document - Fees for the Right to Sell Drugs [2017-03-16]
- Notice - Submission Filing Requirements - Good Manufacturing Practices (GMP)/Drug Establishment Licences (DEL) [2017-02-10]
2016
- Notice - Final Release: Part I - Health Professional Information and Part II - Scientific Information of the Guidance Document - Product Monograph [2016-12-09]
- Notice - Release of the Revised Guidance Document: Information and Submission Requirements for Biosimilar Biologic Drugs [2016-12-02]
- Notice - Validation rules for regulatory transactions submitted to Health Canada in the electronic Common Technical Document (eCTD) format [2016-12-01]
- Notice: Release of the revised Post-Notice of Compliance (NOC) Changes - Quality Guidance [2016-11-03]
- Notice: Limiting the Strength of Acetaminophen to 325 mg per Dosage Unit in Prescription Combination Products [2016-09-15]
- Notice: Interim Order: Naloxone Hydrochloride Nasal Spray [2016-07-06]
- Sponsor Attestation Checklist for Abbreviated New Drug Submissions (ANDS) and Supplements to an Abbreviated New Drug Submission (SANDS) [2016-05-12]
- Notice: Guidance Document: Tamper-resistance Formulations of Opioid Drug Products [2016-03-30]
- Notice: Regulatory Decision Summaries and Submissions Under Review - Increasing transparency Phase II [2016-03-18]
- Communication on changes to the Non-prescription Drug Monograph Attestation Process [2016-01-15]
2015
- Update: Implementation of Plain Language Revisions to Part III: Patient Medication Information and Associated Templates of the Guidance Document: Product Monograph [2015-11-20]
- Notice - Antimicrobial product labelling [2015-11-16]
- Notice: Updates to the Guidance Document: Fees for the Review of Drug Submissions and Applications [2015-11-06]
- Notice - Updates to the Guidance Document: Labelling of Pharmaceutical Drugs for Human Use [2015-09-15]
- Notice: Release of the Final Guidance Document: Drug Submissions Relying on Third-Party Data (Literature and Market Experience) [2015-05-01]
- Notice regarding the release of the revised: Guidance Document: Reconsideration of Decisions Issued for Human Drug Submissions [2015-04-02]
- XOFIGO (radium Ra 223 dichloride): Change in NIST Standard Reference Material - Dear Healthcare Professional Letter [2015-03-19]
2013
- Fact sheet on Drug Shortages [2013-09-13]
- Notice - Regulatory Cooperation Council (RCC) Over-the-Counter (OTC) Products - Common Monograph Working Group - Selection of a Monograph for Alignment [2013-01-10]
2009
2006
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