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Earlier capture
Drug product announcements - Canada.ca
Apr 18, 2025
legacy-hc-2025-04-21
ID 256290
Later capture
Drug product announcements - Canada.ca
Jan 1, 2026
hc-20260101
ID 404950
updated2 sections changed; 9 added; 16 removed
2 sections changed9 added16 removed+134 / -219 linesChange ratio: 33%
--- +++ @@ -1,217 +1,68 @@ 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-Pfizer-BioNTech Comirnaty bivalent BA. 4/5 authorized as a primary series COVID-19 vaccine for individuals 5 years of age and older-[2023-07-06]-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-COVID-19: Nirmatrelvir and ritonavir (Paxlovid) treatment authorized for use in Canada-[2022-01-17]-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-Guidance for market authorization requirements for COVID-19 drugs-[2021-10-29]-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-COVID-19 clinical trials IO and clinical trials records retention: Consultation report-[2021-04-16]-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-2025+Current (2025)+December+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]+Health Canada implementation of the ICH E6(R3) guideline: Notice to stakeholders+[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]+Consultation on Guidance Document: Information and Submission Requirements for Biosimilar Biologic Drugs+[2025-06-10 - 2025-09-08]+March Guidance Document: Preparation of the XML Product Monograph (XML PM) [2025-03-31] Health Canada drafts guidance on co-packaged drug products: Notice@@ -224,6 +75,7 @@ [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@@ -236,16 +88,18 @@ [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 to Stakeholders – Consultation on the Impacts of Implementation of ICH M13A: Bioequivalence for Immediate Release Solid Oral Dosage Forms [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]+Expand all+Hide all+Previous (2024-2006) 2024 Share your views: Consultation on proposed amendments to regulations to address health product shortages in Canada [2024-12-30]@@ -386,8 +240,6 @@ [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@@ -687,8 +539,6 @@ [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@@ -724,6 +574,216 @@ 2006 Notice: Category IV / Labelling Standards Submission Application Process Review [2006-12-19]+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+Pfizer-BioNTech Comirnaty bivalent BA. 4/5 authorized as a primary series COVID-19 vaccine for individuals 5 years of age and older+[2023-07-06]+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 treatmentDiff output was truncated for readability.
