Drug product announcements

December

• Notice to stakeholders – Implementation of ICH M13A: Bioequivalence for immediate release solid oral dosage forms [2025-12-27]
• Consultation: Draft guidance on decentralized clinical trials [2025-12-23]
• Consultation: Modernizing the framework for clinical trials [2025-12-19]
• Bicillin L-A (penicillin G benzathine) in short supply: Notice [2025-12-19]
• Notice: New draft guidance documents on terms and conditions for human and veterinary drugs and drug submissions based on promising evidence of clinical efficacy [2025-12-12]
• Health Canada and the Food and Drug Administration collaborate on generic drug information sharing initiative: Notice [2025-12-01]

October

• Implementation of International Council for Harmonisation (ICH) Q12 - Technical and regulatory considerations for pharmaceutical product lifecycle management: Notice [2025-10-17]
• Release of draft (step 2) ICH Guideline Q3E: Impurities: Guideline for extractables and leachables [2025-10-17]
• Health Canada updates guidance on management of drug submissions and applications: Notice [2025-10-01]

September

• Health Canada updates the guidance on expanded access clinical trials: Notice [2025-09-29]
• Consultation: Draft guidance on the plain language labelling regulations for prescription drugs [2025-09-25]
• Health Canada and the Public Health Agency of Canada's report on red tape reduction [2025-09-08]
• Good manufacturing practices guide for natural health products (GUI-0158) [2025-09-04]
• What we heard: Draft National Priority List of Pediatric Drugs [2025-09-02]

August

• Notice: Classification of topical products containing human-derived exosomes, human extracellular vesicles, and/or human cell-conditioned media [2025-08-14]
• Appendix 1: Established acceptable intake (AI) limits for N-nitrosamine impurities [2025-08-01]
• Updated: Guidance on nitrosamine impurities in medications [2025-08-01]

July

• Spironolactone in short supply: Notice [2025-07-25]
• Dantrolene Sodium for Injection supply in Canada: Notice [2025-07-21]
• Notice of amendment: Nicotine tablets exempted from the Prescription Drug List [2025-07-21]
• Acetaminophen with codeine or oxycodone in short supply: Notice [2025-07-18]
• Notice: Revisions to the Drug Product Database's terminology page [2025-07-04]

June

• Notice to stakeholders – Implementation of ICH M13A: Bioequivalence for immediate release solid oral dosage forms [2025-06-27]
• Guidance document on submission information for biologic drugs (Division 4, Schedule D) [2025-06-23]
• New filing requirements for second language product monographs and package insert mock-ups: Notice [2025-06-20]
• Consultation: Categorization of antimicrobial drugs based on importance in human medicine [2025-06-18]
• Publication of the guidance on data protection under C.08.004.1 of the Food and Drug Regulations: Notice [2025-06-16]

March

• Guidance Document: Preparation of the XML Product Monograph (XML PM) [2025-03-31]
• Health Canada drafts guidance on co-packaged drug products: Notice [2025-03-18]
• Notice: Animal-sourced insulin discontinuation [2025-03-18]
• Guidance for Industry: Preparation of Veterinary New Drug Submissions and Abbreviated New Drug Submissions (New and Generic Drugs) - Quality Requirements [2025-03-14]
• Guidance for Industry: Preparation of Veterinary Abbreviated New Drug Submissions (Generic Drugs) - Clinical and Human Safety Requirements [2025-03-14]
• Notice to stakeholders: Update on the post-market re-evaluation of medically important antimicrobials for veterinary use with unspecified or prolonged durations of use [2025-03-07]

February

• Updated: Guidance Document: Regulatory Requirements for Drug Identification Numbers (DINs) [2025-02-18]
• Updated: Drug Product Database [2025-02-18]
• Policy on terms and conditions for veterinary drugs: Notice to stakeholders [2025-02-12]
• List of needed veterinary drugs [2025-02-07]
• Consultation: Proposal to amend the list of maximum residue limits for veterinary drugs in foods - Proposed MRL 2025-1 [2025-02-05 - 2025-04-21]
• Salbutamol nebules and metered-dose inhalers in short supply: Notice [2025-02-04]

January

• Updates to Mutual Recognition Agreement between Canada and Switzerland [2025-01-31]
• Regulatory cooperation: Canadian guidance on veterinary drug simultaneous reviews with the United States [2025-01-17]
• Notice – Implementation of International Council for Harmonisation (ICH) S1B(R1): Testing for Carcinogenicity of Pharmaceuticals [2025-01-17]
• Publication of revisions to the Guidance Document - Patented Medicines (Notice of Compliance) Regulations: Notice [2025-01-14]

• Share your views: Consultation on proposed amendments to regulations to address health product shortages in Canada [2024-12-30]
• Notice to stakeholders – Publication of the final product monograph guidance document and master template (2024) [2024-12-23]
• Consultation: Release of Draft (Step 2) ICH guideline, ICH M15 and E6(R3) Annex 2 [2024-12-20]
• Implementation: Release of Final (Step 4) ICH guideline, ICH M12 [2024-12-20]
• Guidance on the Food and Drug Regulations for public health emergency drugs [2024-12-18]
• Quality (chemistry and manufacturing) guidance: New Drug Submissions and Abbreviated New Drug Submissions [2024-12-18]
• Guidance document: Labelling of pharmaceutical drugs for human use [2024-12-18]
• Notice: New agile regulatory provisions and updated guidance document for submitting risk management plans [2024-12-18]
• Notice: Updates to the quality (chemistry and manufacturing) guidance: New drug submissions and abbreviated new drug submissions & the guidance document: Labelling of pharmaceutical drugs for human use documents [2024-12-18]
• Fact sheet: What you need to know about antimicrobial medications like antibiotics [2024-12-17]
• Poster: What you should know about antimicrobial medications like antibiotics [2024-12-17]
• 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]

• 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]
• 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]

• 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]

• 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]

• 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]

• 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]

• 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]

• 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]

• 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 - Release of the Final Guidance Document: Notice of Compliance with Conditions (NOC/c) [2016-09-16]
• Notice: Limiting the Strength of Acetaminophen to 325 mg per Dosage Unit in Prescription Combination Products [2016-09-15]
• 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]

• 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]

• 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]

• Submissions Containing Clinical Data from Studies Conducted outside of Canada [2009-06-16]

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