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Capture précédente
What's new: Drug products - Canada.ca
18 avr. 2025
legacy-hc-2025-04-21
ID 145817
Capture suivante
What's new: Drug products - Canada.ca
1 janv. 2026
hc-20260101
ID 404916
updated2 sections changed
2 sections modifiées0 ajoutées0 retirées+394 / -0 lignesVariation: 6%
--- +++ @@ -293,7 +293,441 @@ COVID-19 health product industry [2020-04-01] 2025+December+Register of Innovative Drugs+[2025-12-24]+Consultation: Draft guidance on decentralized clinical trials+[2025-12-23]+Monthly update to the generic submissions under review list+[2025-12-23]+Monthly update to the submissions under review lists+[2025-12-23]+Summary Basis of Decision for Agamree+[2025-12-22]+Summary Basis of Decision for Loqtorzi+[2025-12-22]+Summary Basis of Decision for Oritiniv+[2025-12-22]+Summary Basis of Decision for Osenvelt+[2025-12-22]+Summary Basis of Decision for Stoboclo+[2025-12-22]+Consultation: Modernizing the framework for clinical trials+[2025-12-19]+Notice of Compliance (NOC) Data Extracts+[2025-12-19]+Bicillin L‑A (penicillin G benzathine) in short supply: Notice+[2025-12-19]+Qualifying notice for Wegovy (296143)+[2025-12-19]+Notice: Multiple additions to the Prescription Drug List (PDL)+[2025-12-18]+Appendix 1: Established acceptable intake (AI) limits for N-nitrosamine impurities+[2025-12-17]+Qualifying notice for Lyvdelzi (294551)+[2025-12-16]+Register of Innovative Drugs+[2025-12-12]+Notice: New draft guidance documents on terms and conditions for human and veterinary drugs and drug submissions based on promising evidence of clinical efficacy+[2025-12-12]+Product Monograph Brand Safety Updates – Novembre 2025+[2025-12-11]+Qualifying notice for Eylea (278211)+[2025-12-08]+Updated List of Drugs for an Urgent Public Health Need+[2025-12-08]+Notice of Compliance (NOC) Data Extracts+[2025-12-05]+Scientific Advisory Committee on Mental Health Disorders+[2025-12-03]+Register of Innovative Drugs+[2025-12-02]+Drug Product Database data extract+[2025-12-02]+Health Canada and the Food and Drug Administration collaborate on generic drug information sharing initiative: Notice+[2025-12-01]+November+Updated: Guidance document - Preparation of regulatory activities in non-eCTD format+[2025-11-27]+Updated Register of Certificates of Supplementary Protection and Applications+[2025-11-25]+Qualifying notice for Leqembi (273840)+[2025-11-24]+Notice of Compliance (NOC) Data Extracts+[2025-11-21]+Summary Basis of Decision for Alyftrek+[2025-11-21]+Summary Basis of Decision for Amivas-Artesunate+[2025-11-21]+Summary Basis of Decision for Amtagvi+[2025-11-21]+Summary Basis of Decision for Andembry+[2025-11-21]+Summary Basis of Decision for Blenrep+[2025-11-21]+Summary Basis of Decision for Elahere+[2025-11-21]+Summary Basis of Decision for Lynkuet+[2025-11-21]+Monthly update to the submissions under review lists+[2025-11-20]+Monthly update to the generic submissions under review list+[2025-11-20]+Qualifying notice for Jaypirca (293854)+[2025-11-18]+Product Monograph Brand Safety Updates – October 2025+[2025-11-07]+Notice of Compliance (NOC) Data Extracts+[2025-11-07]+Register of Innovative Drugs+[2025-11-07]+Updated: Filing submissions electronically+[2025-11-05]+Register of Innovative Drugs+[2025-11-04]+Updated Register of Certificates of Supplementary Protection and Applications+[2025-11-04]+Drug Product Database data extract+[2025-11-03]+October+Notice: Multiple additions to the Prescription Drug List (PDL)+[2025-10-30]+Qualifying notice for Enhertu (288114)+[2025-10-28]+What we heard: Draft guidance on co-packaged drug products+[2025-10-27]+Notice of Compliance (NOC) Data Extracts+[2025-10-24]+Register of Innovative Drugs+[2025-10-24]+Updated Register of Certificates of Supplementary Protection and Applications+[2025-10-21]+Register of Innovative Drugs+[2025-10-17]+Monthly update to the submissions under review lists+[2025-10-17]+Monthly update to the generic submissions under review list+[2025-10-17]+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]+Notice of Compliance (NOC) Data Extracts+[2025-10-10]+Product Monograph Brand Safety Updates – September 2025+[2025-10-07]+Drug Product Database data extract+[2025-10-01]+Summary Basis of Decision for Isturisa+[2025-10-01]+Summary Basis of Decision for Pavblu+[2025-10-01]+Summary Basis of Decision for Yesafili+[2025-10-01]+Summary Basis of Decision for Hepcludex+[2025-10-01]+Health Canada updates guidance on management of drug submissions and applications: Notice+[2025-10-01]+Qualifying notice for Amtagvi (293019)+[2025-10-01]+September+Notice of Compliance (NOC) Data Extracts+[2025-09-26]+Monthly update to the submissions under review lists+[2025-09-26]+Register of Innovative Drugs+[2025-09-26]+Monthly update to the generic submissions under review list+[2025-09-25]+Consultation: Draft guidance on the plain language labelling regulations for prescription drugs+[2025-09-25]+Consultation: Adding melatonin for sleep-related use in the pediatric population to the Prescription Drug List+[2025-09-16]+Register of Innovative Drugs+[2025-09-12]+Third party authorization form+[2025-09-10]+Product Monograph Brand Safety Updates – August 2025+[2025-09-10]+Updated: Regulatory enrolment process+[2025-09-10]+Notice of amendment: Addition of melatonin to the Prescription Drug List+[2025-09-09]+Register of Innovative Drugs+[2025-09-08]+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]+Drug Product Database data extracts+[2025-09-02]+August+Notice of Compliance (NOC) Data Extracts+[2025-08-29]+Register of Innovative Drugs+[2025-08-28]+Notice: Multiple additions to the Prescription Drug List (PDL)+[2025-08-28]+Updated Register of Certificates of Supplementary Protection and Applications+[2025-08-27]+Monthly update to the submissions under review lists+[2025-08-21]+Register of Innovative Drugs+[2025-08-21]+Monthly update to the generic submissions under review lists+[2025-08-21]+Summary Basis of Decision for Aflivu+[2025-08-21]+Summary Basis of Decision for Augtyro+[2025-08-21]+Summary Basis of Decision for Iqirvo+[2025-08-21]+Summary Basis of Decision for Piasky+[2025-08-21]+Summary Basis of Decision for Tepezza+[2025-08-21]+Summary Basis of Decision for Vanflyta+[2025-08-21]+Drug Product Database data extract – Update+[2025-08-19]+Notice of Compliance (NOC) Data Extracts+[2025-08-15]+Notice: Classification of topical products containing human-derived exosomes, human extracellular vesicles, and/or human cell-conditioned media+[2025-08-14]+Product Monograph Brand Safety Updates – July 2025+[2025-08-13]+Qualifying notice for Braftovi (292474)+[2025-08-08]+Register of Innovative Drugs+[2025-08-07]+Drug Product Database data extracts+[2025-08-01]+Register of Innovative Drugs+[2025-08-01]+Notice of Compliance (NOC) Data Extracts+[2025-08-01]+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+Updated Register of Certificates of Supplementary Protection and Applications+[2025-07-31]+Monthly update to the submissions under review lists+[2025-07-31]+Monthly update to the generic submissions under review lists+[2025-07-31]+Register of Innovative Drugs+[2025-07-28]+Statistical Report 2024/2025 for the Patented Medicines (Notice of Compliance) Regulations, Data Protection and Certificates of Supplementary Protection+[2025-07-25]+Spironolactone in short supply: Notice+[2025-07-25]+Updated Register of Certificates of Supplementary Protection and Applications+[2025-07-24]+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]+Notice of Compliance (NOC) Data Extracts+[2025-07-18]+Acetaminophen with codeine or oxycodone in short supply: Notice+[2025-07-18]+Updated Register of Certificates of Supplementary Protection and Applications+[2025-07-18]+Register of Innovative Drugs+[2025-07-18]+Register of Innovative Drugs+[2025-07-15]+Updated Register of Certificates of Supplementary Protection and Applications+[2025-07-15]+Product Monograph Brand Safety Updates – June 2025+[2025-07-15]+Notice of intent: Revisions to the Prescription Drug List for nicotine buccal pouches+[2025-07-14]+Notice of intent: Exempting nicotine tablets from the Prescription Drug List+[2025-07-14]+Qualifying notice for Zynlonta (284436)+[2025-07-14]+Notice of Compliance (NOC) Data Extracts+[2025-07-04]+Notice: Revisions to the Drug Product Database's terminology page+[2025-07-04]+Updated List of Drugs for an Urgent Public Health Need+[2025-07-04]+Register of Innovative Drugs+[2025-07-04]+Summary Basis of Decision for Winrevair+[2025-07-03]+Summary Basis of Decision for Zilbrysq+[2025-07-03]+Summary Basis of Decision for Zynlonta+[2025-07-03]+Summary Basis of Decision for Zynyz+[2025-07-03]+DPD Extracts+[2025-07-02]+Summary Basis of Decision for Ringza+[2025-07-02]+Summary Basis of Decision for Rystiggo+[2025-07-02]+Summary Basis of Decision for Skyclarys+[2025-07-02]+Summary Basis of Decision for Steqeyma and Steqeyma I.V.+[2025-07-02]+Summary Basis of Decision for Tibsovo+[2025-07-02]+Summary Basis of Decision for Tyenne+[2025-07-02]+Summary Basis of Decision for Tzield+[2025-07-02]+Summary Basis of Decision for Vabomere+[2025-07-02]+Summary Basis of Decision for Veozah+[2025-07-02]+Summary Basis of Decision for Vyloy+[2025-07-02]+June+Updated: Labels and packages certification form for prescription products+[2025-06-30]+Notice to stakeholders – Implementation of ICH M13A: Bioequivalence for immediate release solid oral dosage forms+[2025-06-27]+Q13: Continuous manufacturing of drug substances and drug products+[2025-06-27]+Q5A(R2): Viral safety evaluation of biotechnology products derived from cell lines of human or animal origin+[2025-06-27]+Q3C(R9): Impurities: Residual solvents+[2025-06-27]+Release of draft (step 2) ICH guideline Q1: Stability testing of drug substances and drug products+[2025-06-27]+Release of draft (Step 2) ICH guideline M13B: Bioequivalence for immediate-release solid oral dosage forms+[2025-06-27]+Release of draft (Step 2) ICH guideline M4Q(R2): Common Technical Document (CTD)-Quality+[2025-06-27]+Release of draft (Step 2) ICH guideline E20: Adaptive clinical trials+[2025-06-27]+Release of draft (Step 2) ICH guideline E21: Inclusion of pregnant and breastfeeding individuals in clinical trials+[2025-06-27]+Release of draft (Step 2) ICH M11: Clinical electronic Structured Harmonised Protocol (CeSHarP) – Technical specification+[2025-06-27]+Qualifying notice for Tagrisso (288417)+[2025-06-26]+Updated Register of Certificates of Supplementary Protection and Applications+[2025-06-26]+Monthly update to the submissions under review lists+[2025-06-25]+Monthly update to the generic submissions under review list+[2025-06-25]+Notice: Multiple additions to the Prescription Drug List (PDL)+[2025-06-24]+Summary Basis of Decision for Miebo+[2025-06-24]+Summary Basis of Decision for mResvia+[2025-06-24]+Summary Basis of Decision for Nduvra+[2025-06-24]+Summary Basis of Decision for Ojjaara+[2025-06-24]+Summary Basis of Decision for Omlyclo+[2025-06-24]+Summary Basis of Decision for Otulfi and Otulfi I.V.+[2025-06-24]+Summary Basis of Decision for Pexegra+[2025-06-24]+Summary Basis of Decision for Pombiliti+[2025-06-24]+Summary Basis of Decision for Pyzchiva and Pyzchiva I.V.+[2025-06-24]+Summary Basis of Decision for Qalsody+[2025-06-24]+Summary Basis of Decision for Rebyota+[2025-06-24]+Register of Innovative Drugs+[2025-06-24]+Notice of Compliance (NOC) Data Extracts+[2025-06-23]+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]+Updated Register of Certificates of Supplementary Protection and Applications+[2025-06-20]+Summary Basis of Decision for Altuviiio+[2025-06-18]+Summary Basis of Decision for Baxdela+[2025-06-18]+Summary Basis of Decision for Casgevy+[2025-06-18]+Summary Basis of Decision for Daybue+[2025-06-18]+Summary Basis of Decision for Fabhalta+[2025-06-18]+Summary Basis of Decision for Filra+[2025-06-18]+Summary Basis of Decision for Imdelltra+[2025-06-18]+Summary Basis of Decision for Itovebi+[2025-06-18]+Summary Basis of Decision for Kavigale+[2025-06-18]+Summary Basis of Decision for Lazcluze+[2025-06-18]+Qualifying notice for Iqirvo (287772)+[2025-06-17]+Publication of the guidance on data protection under C.08.004.1 of the Food and Drug Regulations: Notice+[2025-06-16]+Register of Innovative Drugs+[2025-06-12]+Updated Register of Certificates of Supplementary Protection and Applications+[2025-06-11]+Product Monograph Brand Safety Updates – May 2025+[2025-06-09]+Notice of Compliance (NOC) Data Extracts+[2025-06-05]+Updated Register of Certificates of Supplementary Protection and ApplicationsLa sortie du diff a été tronquée pour la lisibilité.
