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Drug Products

ARCHIVED - Consultation - New Labelling Standard (Oral Adult Decongestant)

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Date modified:: 2015-07-28

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Drug Products

Draft Guidance Document - Administrative Processing of Submissions and Applications Involving Human or Disinfectant Drugs
Notice - Draft Guidance Document: Administrative Processing of Drug Submissions and Applications Involving Human or Disinfectant Drugs
Notice: Proposed Policy on Bioequivalence Standards for Highly Variable Drug Products
Draft Guidance Document - Disclosure of Confidential Business Information under Paragraph 21.1(3)(c) of the Food and Drugs Act
Release of Draft Guidance Document: Disclosure of Confidential Business Information under Paragraph 21.1(3)(c) of the Food and Drugs Act
Draft Guidance Document: Use of Certificates of Suitability as supporting information in Drug Submissions
Draft Guidance Document - Biopharmaceutics Classification System Based Biowaiver
Consultation on Health Canada's Public Clinical Trials Database
Consultation on the Draft Guidance Document: Tamper-Resistant Formulations of Opioid Drug Product Submissions
Consultation on the Draft Guidance Document: Master Files (MFs) - Procedures and Administrative Requirements
Guidance Document - Reconsideration of Decisions Issued for Human Drug Submissions
Draft Guidance Document - Release of draft revised: Guidance Document: Reconsideration of Decisions Issued for Human Drug Submissions
ARCHIVED - Consultation - New Labelling Standard (Oral Adult Decongestant)
Release of Draft (Step 2) International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) Guidance: M4E(R2)
Notice: Release of Draft (Step 2) ICH Guidance: M7 Addendum - Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk
Release of Draft (Step 2) International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) Guidance: M8 - Common Technical Document: Implementation Guide
Release of draft Part I: Health Professional Information and Part II: Scientific Information - Guidance Document: Product Monograph
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
International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use – S1: Proposed Change to Rodent Carcinogenicity Testing of Pharmaceuticals - Notice for Public Input
Release of Draft (Step 2) ICH Guidance Document: S3A Q&A: Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure - Focus on Microsampling
ARCHIVED - Public Consultation on the Notification of Drug Shortages
ARCHIVED - Consultation on the Draft Guidance Document: Submissions Relying on Third-Party Data [Literature and Market Experience]
Consultation on the Amendments to the Food and Drugs Act: Guide to New Authorities (power to require and disclose information, order a label change and order a recall)
Protecting Canadians from Unsafe Drugs Act Transparency Needs-based Assessment
Consultation on the Draft Guidance Document: Administrative Processing of Drug Submissions and Applications Involving Human or Disinfectant Drugs
Proposed Policy on Bioequivalence Standards for Highly Variable Drug Products
Draft Guidance Document - Disclosure of Confidential Business Information under Paragraph 21.1(3)(c) of the Food and Drugs Act
Consultation on the Health Canada Draft Guidance Document: Use of Certificates of Suitability as supporting information in Drug Submissions
Draft Guidance Document - Cancellation of a Drug Identification Number (DIN) and Notification of the Discontinuation of Sales
Consultation: Draft –Guide to reporting drug shortages and discontinuations
Release of Draft (Step 2) International Council for Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) Guidance: E17: General principles on planning/designing Multi-Regional Clinical Trials
Release of Draft (Step 2) ICH Guidance Document: E18: Genomic Sampling and Management of Genomic Data
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
Release of International Council on Harmonisation (ICH) Document: Good Clinical Practice (GCP) "Renovation" Reflection Paper
Notice: 2016 Master File Cost Recovery Consultation
Consultation: Release of Draft (Step 2) ICH S9 Q&As: Questions and Answers: Nonclinical Evaluation for Anticancer Pharmaceuticals
Consultation on Health Product Transparency Initiatives
Draft Guidance Document: Certified Product Information Document- Chemical Entities (CPID-CE)
Notice Regarding Dear Health Care Professional Letters for Notice of Compliance with Conditions
Notice - Release of Draft Guidance Document: Disinfectant Drugs (2013) for Consultation
Draft Guidance Document: Master Files (MFs) - Procedures and Administrative Requirements
Notice: Release of Draft (Step 2) International Council for Harmonisation (ICH) Guidance: E11(R1): Addendum: Clinical Investigation of Medicinal Products in the Pediatric Population
Release of Draft (Step 2) International Council for Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use Guidance: E17: Principles on planning/designing Multi-Regional Clinical Trials
Notice: Release of Draft (Step 2) ICH Guidance Document: E18: Genomic Sampling and Management of Genomic Data
Consultation - Release of Draft (Step 2) International Council on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use : Guidance: E6 Integrated Addendum: Good Clinical Practice
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 – April 2015
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
Notice: Release of International Council on Harmonisation (ICH) Document: Good Clinical Practice (GCP) "Renovation" Reflection Paper
Guidance Document - Non-prescription Oral Adult Decongestant Cough and Cold Labelling Standard
Consultation on the Prescription Drug List: Diclofenac
Consultation on the Prescription Drug List: Esomeprazole
Consultation on the Prescription Drug List: Fluticasone propionate
Consultation on the Prescription Drug List: Hydrocortisone
Consultation on the Prescription Drug List: Hyoscine butylbromide
Consultation on the Prescription Drug List: Ibuprofen
Consultation on the Prescription Drug List: Levonorgestrel
Consultation on the Prescription Drug List: Lovastatin
Consultation on the Prescription Drug List: Minoxidil
Consultation on the Prescription Drug List: Mometasone furoate monohydrate
Consultation on the Prescription Drug List: Naloxone
ARCHIVED - Consultation on the Prescription Drug List: Naproxen
Consultation on the Prescription Drug List: Omeprazole
Consultation on the Prescription Drug List: Polymyxin B
Consultation on the Prescription Drug List: Triamcinolone acetonide
Consultation on the Prescription Drug List: Hydroquinone
Consultation on the Prescription Drug List: Naloxone
Release of Draft (Step 2) ICH Guidance: M4E(R2): Enhancing the Format and Structure of Benefit-Risk Information in ICH
Release of Draft (Step 2) ICH Guidance: M7 Addendum - Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk – July 2015
Release of Draft (Step 2) International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals on Human Use (ICH) Guidance: M8 - Electronic Common Technical Document: Implementation Guide
2016 Master File Cost Recovery Consultation
Consultation on the new Prescription Drug List
Consultation Document: Draft Guidance Document - Determining Prescription Status for Human and Veterinary Drugs
Notice: Prescription Drug List (PDL): Esomeprazole
Notice: Prescription Drug List (PDL): Fluticasone propionate
Notice: Prescription Drug List (PDL): Hydrocortisone
Notice: Prescription Drug List (PDL): Hyoscine butylbromide
Notice: Prescription Drug List (PDL): Ibuprofen
Notice: Prescription Drug List (PDL): Levonorgestrel
Notice: Prescription Drug List (PDL): Lovastatin
Notice: Prescription Drug List (PDL): Mometasone furoate monohydrate
Notice: Prescription Drug List (PDL): Naloxone
Notice: Prescription Drug List (PDL): Naproxen
Notice: Prescription Drug List (PDL): Polymyxin B
Notice: Prescription Drug List (PDL): Triamcinolone acetonide
Notice of Consultation: Prescription Drug List (PDL): Hydroquinone
Notice of Consultation: Prescription Drug List (PDL): Naloxone Qualifier Change
Notice - Release of draft Part I: Health Professional Information and Part II: Scientific Information - Guidance Document: Product Monograph
Notice: 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
Release of Draft (Step 2) ICH Guidance: Q3C(R6): Impurities: Guideline for Residual Solvents
Draft Guidance Document: Addendum - Quality (Chemistry and Manufacturing) Guidance: Questions and Answers
Draft: Glossary of Quality Terms
Draft Guidance Document: Quality (Chemistry and Manufacturing) Guidance: New Drug Submissions (NDSs) and Abbreviated New Drug Submissions (ANDSs)
Consultation on the Health Canada Draft Guidance Document: Quality (Chemistry and Manufacturing) Guidance: New Drug Submissions (NDSs) and Abbreviated New Drug Submissions (ANDSs)
Notice: Health Canada and United States Food and Drug Administration (US FDA) Joint Public Consultation on International Council on Harmonisation (ICH) Guidelines for Registration of Pharmaceuticals for Human Use
Notice: Health Canada and United States Food and Drug Administration Joint Public Consultation on International Council on Harmonisation (ICH) Guidelines for Registration of Pharmaceuticals for Human Use
International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use: Proposed Change to Rodent Carcinogenicity Testing of Pharmaceuticals - Public Input Notice
Release of Draft (Step 2) International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) Guidance
S3A Questions and Answers: Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure - Focus on Microsampling.
Release of Draft (Step 2) International Council for Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use: S9 Q&As: Questions and Answers: Nonclinical Evaluation for Anticancer Pharmaceuticals
Consultation on Possible Changes to the Food and Drug Regulations: Generic Drug Equivalence and Related Terminology
Possible Changes to the Food and Drug Regulations: Generic Drug Equivalence and Related Terminology
Consultation on Proposed Modification to Bioequivalence Standards for Multiphasic Modified-Release Drug Products
Notice: Proposed Modification to Bioequivalence Standards for Multiphasic Modified-Release Drug Products
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
Consultation: proposals for prescription drug transparency
Notice: Release of Draft (Step 2) ICH Guidance: S5(R3): Revision of S5 Guideline on Detection of Toxicity to Reproduction for Human Pharmaceuticals
Notice: Release of Draft (Step 2) ICH Guidance: E9(R1): Addendum: Statistical Principles for Clinical Trials
Notice: Health Canada and United States Food and Drug Administration Joint Public Consultation on International Council foron Harmonisation (ICH) Guidelines for Registration of Pharmaceuticals for Human Use
Notice: Release of Draft (Step 2) ICH Guidance: Q12: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management
Consultation for Mandatory Requirements of using Electronic Common Technical Document (eCTD) Format when Submitting Master Files (MFs)
Notice - Consultation for Mandatory Requirements of using Electronic Common Technical Document (eCTD) Format when Submitting Master Files (MFs)
Consultation: Release of Draft (Step 2) ICH Guidance: Q3D: Guideline for Elemental Impurities (Cadmium Inhalation PDE revision)
Radiopharmaceuticals, Kits, and Generators – Submission Information for Schedule C Drugs: Draft Guidance Document for Consultation
Release of ICH M9 Guidance Draft
Consultation on the Pause the Clock proposal for pre-market submissions and applications
Consultation on proposed revisions to the Guidance Document: Management of Drug Submissions
Pause-the-Clock Proposal for Drug and Medical Device Establishment Licence Applications
Consultation on the Pause-the-Clock Proposal for Drug and Medical Device Establishment Licence Applications
Health Canada Requests Feedback on Potential Impacts and Uses if Company Names were added to the Generic Submissions Under Review List
Consultation Notice: Health Canada Requests Feedback on Potential Impacts and Uses if Company Names were added to the Generic Submissions Under Review List
Consultation – Proposed new regulatory activity types for transactions filed to the Marketed Health Products Directorate (MHPD)
Consultation on Draft Guidance Document: Regulatory Requirements for Drug Identification Numbers (DINS)
Draft Guidance Document - Regulatory requirements for Drug Identification Numbers (DINs)
Notice: For Consultation: Draft (Step 2) ICH Guidance: M10 Bioanalytical Method Validation
Consultation of Draft Guidance Documents: Identifying and Labelling Medicinal Ingredients, Generic Drug Equivalence: Medicinal Ingredients
Consultation - Draft Guidance Document for Industry and Practitioners on the Special Access Program (SAP) for Drugs
Consultation on the Draft Guidance: Public or Canadian Armed Forces Health Emergencies - Drugs for Immediate Use or Stockpiling
Notice to Stakeholders: Draft Guidance: Public or Canadian Armed Forces Health Emergencies - Drugs for Immediate Use or Stockpiling
Structured Format for Product Monographs
Notice - Release of Draft (Step 2) ICH Guidance: E19 Optimisation of Safety Data Collection
Notice: Consultation: Release of Draft (Step 2) ICH Guidance: E8(R1) Revision on General Considerations for Clinical Trials
Draft guidance document: Canadian Module 1 Technical Implementation Guide for the Electronic Common Technical Document (eCTD) v4.0 Format
Enabling advanced therapeutic products and modernizing the regulation of clinical trials
Notice of consultation on the Prescription Drug List (PDL): Epinephrine chloride (topical solution)
Update: 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

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