Drug Products
Current Consultations
2023
- Consultation on the changes to the 2020 product monograph guidance and master template [2023-09-15]
- Share your views: Draft Pre-market guidance for machine learning-enabled medical devicess [2023-08-30 – 2023-10-29]
- Consultation: Draft guidance on the preparation of the product monograph in XML format [2023-08-15]
- Consultation: Release of Draft (Step 2) ICH guideline, ICH E6(R3) [2023-06-21]
- Consultation on improving access to drugs and other health products in Canada [2023-06-05]
- Consultation: Proposed application of the definition of Canadian Reference Product (CRP) [2023-03-27]
- 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- Consultation: Registration of Clinical Trials and Public Disclosure of Results: Draft Guidance and Public Search Portal [2023-02-23]
- Notice: Joint Health Canada, Canada and FDA, United States Public Consultation on ICH [2023-01-17]
2022
- Notice: Joint Health Canada, Canada and FDA, United States Public Consultation on ICH [2023-01-17]
- 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]
- Consultation Extension: Draft (Step 2) ICH Guideline E11A [2022-09-29]
- Consultation: Release of Draft (Step 2) ICH guideline, ICH M12 [2022-07-29]
- Consultation: Exceptions to the Prescription Drug List [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]
- Consultation: Release of Draft ICH : Q9(R1): Quality Risk Management [2022-01-14]
2021
- Notice of Consultation on the Prescription Drug List (PDL): Betaine [2021-12-22]
- 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]
- 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]
- Notice of Consultation on the Prescription Drug List (PDL): Brimonidine [2021-09-01]
- 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]
- Consultation: Release of draft revised guidance documents on Post-Notice of Compliance (NOC) Changes – Quality, for stakeholder consultation [2021-08-06]
- 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]
- Consultation on the Issue identification paper: Drug-device combination products draft [2021-05-10]
- Notice of Consultation on the Prescription Drug List (PDL): Metamizole (dipyrone) [2021-04-23]
- 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]
- Consultation: Electronic media in prescription drug labelling draft guidance document [2021-03-12]
2020
- Consultation: ICH Reflection Paper: Proposed ICH Guideline Work to Advance Patient-Focused Drug Development [2020-12-16]
- 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 [2020-09-29]
2019
- Notice of consultation on the Prescription Drug List (PDL): Epinephrine chloride (topical solution) [2019-08-12]
- Agile regulations for advanced therapeutic products and clinical trials [2019-07-18]
- Consultation on: Draft Guidance: Canadian Module 1 Technical Implementation Guide for the Electronic Common Technical Document (eCTD) v.4.0 Format [2019-06-26]
- Consultation on the Draft Guidance: Public or Canadian Armed Forces Health Emergencies - Drugs for Immediate Use or Stockpiling [2019-05-10]
- Notice to Stakeholders: Draft Guidance: Public or Canadian Armed Forces Health Emergencies - Drugs for Immediate Use or Stockpiling [2019-05-10]
- Consultation - Draft Guidance Document for Industry and Practitioners on the Special Access Program (SAP) for Drugs [2019-05-10]
- Notice to Stakeholders: Draft Guidance Document for Industry and Practitioners on the Special Access Program (SAP) for Drugs [2019-05-10]
2018
- Consultation on the Pause-the-Clock Proposal for Drug and Medical Device Establishment Licence Applications[2018-10-31]
- Pause-the-Clock Proposal for Drug and Medical Device Establishment Licence Applications [2018-10-31]
- Consultation on the Pause the Clock proposal for pre-market submissions and applications [2018-08-10]
- Consultations on improving the regulatory review of drugs and devices
2017
- Consultation on fee proposal for drugs and medical devices [2017-10-11]
- Consultation on a new Drug Facts Table for Non-prescription Drugs Guidance Document supporting improved labelling for Canadians [2017-02-20]
2016
- Release of Draft (Step 2) International Council for Harmonisation (ICH) Guidance: Q11 Questions and Answers: Selection and Justification of Starting Materials for the Manufacture of Drug Substances [2016-12-19]
- 2016 Master File (MF) Cost Recovery Consultation [2016-11-29]
- ICH E11(R1) Addendum: Clinical Investigation of Medicinal Products in the Pediatric Population [2016-11-04]
- Consultation on the Health Canada Draft Guidance Document: Quality (Chemistry and Manufacturing) Guidance: New Drug Submissions (NDSs) and Abbreviated New Drug Submissions (ANDSs) [2016-10-06]
- Consultation - Regulation of self-care products [2016-09-08]
- Notice: Health Canada and United States Food and Drug Administration (US FDA) Joint Public Consultation on International Conference on Harmonisation (ICH) Guidelines for Registration of Pharmaceuticals for Human Use [2016-08-29]
- Consultation: Release of Draft (Step 2) ICH E17: General principles on planning/designing Multi-Regional Clinical Trials [2016-07-29]
- Consultation: Release of Draft (Step 2) ICH S9 Q&As: Questions and Answers: Nonclinical Evaluation for Anticancer Pharmaceuticals [2016-07-29]
- Consultation - Draft - Guide to reporting drug shortages and discontinuations [2016-06-30]
- Consultation on the Draft Guidance Document - Cancellation of a Drug Identification Number (DIN) and Notification of the Discontinuation of Sales [2016-06-30]
- Consultation - Release of Draft (Step 2) ICH Guidance Document: S3A Q&A: Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure - Focus on Microsampling [2016-06-10]
- Consultation Regarding Dear Health Care Professional Letters for Notice of Compliance with Conditions [2016-04-15]
- Health Canada and United States Food and Drug Administration Joint Public Consultation on International Council on Harmonisation Guidelines for Registration of Pharmaceuticals for Human Use [2016-03-24]
- Consultation - Prescription Drug List (PDL): Naloxone [2016-01-14]
- Consultation - Release of Draft (Step 2) ICH Guidance Document E18: Genomic Sampling and Management of Genomic Data [2016-01-08]
Past Consultations
2017
- Consultation on the Draft Guidance Document: Administrative Processing of Drug Submissions and Applications Involving Human or Disinfectant Drugs [2017-02-17]
- Consultation: Release of International Council on Harmonisation (ICH) Document: Good Clinical Practice (GCP) "Renovation" Reflection Paper [2017-02-02]
- Consultation on the Prescription Drug List: Hydroquinone [2017-02-01]
- Consultation on the Health Canada Draft Guidance Document: Use of Certificates of Suitability as supporting information in Drug Submissions [2017-01-31]
- Consultation on the Prescription Drug List: Naloxone [2017-01-24]
2016
- Consultation on the Draft Guidance Document: Master Files (MFs) - Procedures and Administrative Requirements [2016-02-15]
- Consultation on Health Product Transparency Initiatives [2016-01-25]
2015
- Consultation - Prescription Drug List (PDL): Fluticasone propionate [2015-11-27]
- Consultation - Release of Draft (Step 2) International Council on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) Guidance: E6 Integrated Addendum: Good Clinical Practice [2015-11-25]
- Notice: Health Canada and United States Food and Drug Administration Joint Public Consultation on International Conference on Harmonisation Guidelines for Registration of Pharmaceuticals for Human Use [2015-10-27]
- Consultation on the Prescription Drug List: Hyoscine butylbromide [2015-10-16]
- Consultation - Prescription Drug List (PDL): Ibuprofen [2015-10-02]
- Consultation - Prescription Drug List (PDL): Esomeprazole [2015-10-02]
- Consultation - Release of Draft (Step 2) International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) Guidance: Q3C(R6): Impurities: Guideline for Residual Solvents [2015-08-19]
- Consultation - Release of Draft (Step 2) International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) Guidance: M4E(R2): Enhancing the Format and Structure of Benefit-Risk Information in ICH [2015-08-19]
- Consultation - Release of Draft (Step 2) ICH Guidance: M7 Addendum - Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk [2015-07-30]
- Proposed Policy on Bioequivalence Standards for Highly Variable Drug Products [2015-06-26]
- Consultation - Prescription Drug List (PDL): Polymyxin B [2015-06-19]
- Consultation - New Labelling Standard (Oral Adult Decongestant) [2015-06-01]
- Notice: Health Canada and United States Food and Drug Administration Joint Public Consultation on International Conference on Harmonisation Guidelines for Registration of Pharmaceuticals for Human Use [2015-04-10]
- Protecting Canadians from Unsafe Drugs Act Transparency Needs-based Assessment [2015-03-25]
- Consultation on the Amendments to the Food and Drugs Act: Guide to New Authorities (power to require & disclose information, power to order a label change and power to order a recall) [2015-03-25]
- Consultation - Release of Draft (Step 2) International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use Guidance: M8 - Electronic Common Technical Document: Implementation Guide [2015-03-16]
2014
- Consultation on the Draft Guidance Document: Tamper-Resistant Formulations of Opioid Drug Submissions [2014-10-14]
- Consultation - Prescription Drug List (PDL): Mometasone furoate monohydrate [2014-11-27]
- Consultation on the Draft Guidance Document: Submissions Relying on Third-Party Data [Literature and Market Experience] [2014-06-13]
- Consultation - Prescription Drug List (PDL): Lovastatin [2014-06-04]
- Consultation - revision of listing for Adrenocortical hormones or their salts or derivatives on the Prescription Drug List [2014-03-17]
- Consultation - revision of listing for Hydrocortisone on the Prescription Drug List [2014-02-20]
- Consultation on the Release of draft Part I: Health Professional Information and Part II: Scientific Information - Guidance Document: Product Monograph [2014-12-19]
- Notice - Prescription Drug List (PDL): Levonorgestrel [2014-08-15]
- Consultation on the release of draft revised Guidance Document: Reconsideration of Decisions Issued for Human Drug Submissions [2014-08-12]
- Consultation - Prescription Drug List (PDL): Naproxen [2014-06-04]
- Public Consultation on the Notification of Drug Shortages [2014-05-22]
2013
- Consultation - International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) S1: Proposed Change to Rodent Carcinogenicity Testing of Pharmaceuticals - Regulatory Notice for Public Input [2013-02-05]
- Consultation - revision of listing for Diclofenac on the Prescription Drug List [2013-11-05]
- Consultation - revision of listing for Omeprazole on the Prescription Drug List [2013-11-05]
- Consultation - revision of listing for Minoxidil on the Prescription Drug List [2013-11-05]
2012
- Consultation on the new Prescription Drug List [2012-12-24]
- Consultation on Health Canada's Public Clinical Trials Database [2012-12-13]
- Regulations Amending the Food and Drug Regulations (1475 - Good Manufacturing Practices) [2012-09-29]
- Draft Guidance Document: Biopharmaceutics Classification System Based Biowaver - Comment period extended [2012-08-21]
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