What's New - Drug Products

Files added to the Web site are also posted here in the What's New section for three weeks. Once you have browsed through the entire site, all you need to do to keep current is make sure you visit this page more than once every three weeks.

Weekly Drug NOC updates

2019

January

Notice of Compliance (NOC) Data Extracts [2019-01-18]
Post-Authorization Activity Table (PAAT) for Tudorza Genuair [2019-01-17]
Regulatory Decision Summary for XERMELO [2019-01-17]
Post-Authorization Activity Table (PAAT) for Xofigo [2019-01-17]
Regulatory Decision Summary for OXYCODONE (*XTAMPZA ER) [2019-01-17]
Consultation Notice: Health Canada Requests Feedback on Potential Impacts and Uses if Company Names were added to the Generic Submissions Under Review List [2019-01-17]
Post-Authorization Activity Table (PAAT) for Pheburane [2019-01-17]
Post-Authorization Activity Table (PAAT) for Plegridy [2019-01-17]
Post-Authorization Activity Table (PAAT) for Pomalyst [2019-01-17]
Summary Basis of Decision (SBD) for RAYALDEE [2019-01-17]
Post-Authorization Activity Table (PAAT) for Shingrix [2019-01-17]
Post-Authorization Activity Table (PAAT) for Signifor [2019-01-17]
Post-Authorization Activity Table (PAAT) for Strensiq [2019-01-17]
Regulatory Decision Summary for SUBLOCADE [2019-01-17]
Post-Authorization Activity Table (PAAT) for Sylvant [2019-01-17]
Post-Authorization Activity Table (PAAT) for Tafinlar [2019-01-17]
Post-Authorization Activity Table (PAAT) for Tecentriq [2019-01-17]
Regulatory Decision Summary for TRAJENTA [2019-01-17]
Updated Register of Certificates of Supplementary Protection and Applications [2019-01-16]
Notice for Consultation – Proposed new regulatory activity types for transactions filed to the Marketed Health Products Directorate (MHPD) [2019-01-15]
Post-Authorization Activity Table (PAAT) for Fycompa [2019-01-14]
Regulatory Decision Summary for Gilenya [2019-01-14]
Summary Basis of Decision (SBD) for Hemlibra [2019-01-14]
Post-Authorization Activity Table (PAAT) for Idelvion [2019-01-14]
Regulatory Decision Summary for Invokana [2019-01-14]
Regulatory Decision Summary for JIVI [2019-01-14]
Post-Authorization Activity Table (PAAT) for Kevzara [2019-01-14]
Summary of Cancellation for NUCALA (Control number 212242) [2019-01-14]
Post-Authorization Activity Table (PAAT) for Obizur [2019-01-14]
Summary Basis of Decision for Olumiant [2019-01-14]
Post-Authorization Activity Table (PAAT) for Orfadin [2019-01-14]
Regulatory Decision Summary for Perjeta [2019-01-14]
Updated List of Drugs for an Urgent Public Health Need [2019-01-11]
Notice of Compliance (NOC) Data Extracts [2019-01-11]
Post-Authorization Activity Table (PAAT) for Afstyla [2019-01-10]
Post-Authorization Activity Table (PAAT) for Anoro Ellipta [2019-01-10]
Regulatory Decision Summary for Brineura [2019-01-10]
Post-Authorization Activity Table (PAAT) for Brivlera [2019-01-10]
Regulatory Decision Summary for Crysvita [2019-01-10]
Post-Authorization Activity Table (PAAT) for Dotarem [2019-01-10]
Post-Authorization Activity Table (PAAT) for Duavive [2019-01-10]
Post-Authorization Activity Table (PAAT) for Elelyso [2019-01-10]
Post-Authorization Activity Table (PAAT) for Empliciti [2019-01-10]
Post-Authorization Activity Table (PAAT) for Entresto [2019-01-10]
Post-Authorization Activity Table (PAAT) for Esbriet [2019-01-10]
Post-Authorization Activity Table (PAAT) for Forxiga [2019-01-10]
Updated Register of Certificates of Supplementary Protection and Applications [2019-01-10]
Product Monograph Brand Safety Updates – December 2018 [2019-01-10]
Register of Innovative Drugs [2019-01-07]
DPD Extracts [2019-01-02]
Notice of Compliance (NOC) Data Extracts [2019-01-04]

2018

December

Product Monograph Brand Safety Updates – November 2018 [2018-12-28]
Generic Submissions Under Review [2018-12-21]
Submissions Under Review [2018-12-21]
Notice of Compliance (NOC) Data Extracts [2018-12-28]
Notice: Prescription Drug List (PDL): Multiple additions [2018-12-27]
Drug and Medical Device Databases [2018-12-27]
Register of Innovative Drugs [2018-12-20]
Updated Register of Certificates of Supplementary Protection and Applications [2018-12-21]
Notice of Compliance (NOC) Data Extracts [2018-12-21]
Post-Authorization Activity Table (PAAT) for Zinbryta [2018-12-21]
Post-Authorization Activity Table (PAAT) for Xofigo [2018-12-21]
Post-Authorization Activity Table (PAAT) for Vimizim [2018-12-21]
Regulatory Decision Summary for Unituxin [2018-12-21]
Post-Authorization Activity Table (PAAT) for Trumenba [2018-12-21]
Post-Authorization Activity Table (PAAT) for Tivicay [2018-12-21]
Post-Authorization Activity Table (PAAT) for Stribild [2018-12-21]
Regulatory Decision Summary for Repatha [2018-12-21]
Regulatory Decision Summary for Opdivo [2018-12-21]
Post-Authorization Activity Table (PAAT) for Dymista [2018-12-21]
Post-Authorization Activity Table (PAAT) for Arepanrix H5N1 [2018-12-21]
Regulatory Decision Summary for Adynovate [2018-12-21]
Health Canada's Action Plan on Medical Devices: Continuously Improving Safety, Effectiveness and Quality [2018-12-20]
Updated List of Drugs for an Urgent Public Health Need [2018-12-18]
Updated Register of Certificates of Supplementary Protection and Applications [2018-12-17]
Register of Innovative Drugs [2018-12-14]
Notice of Compliance (NOC) Data Extracts [2018-12-14]
Notice - Release of ICH Q3C(R7): Impurities: Guideline for Residual Solvents [2018-12-13]
Post-Authorization Activity Table (PAAT) for Besponsa [2018-12-12]
Post-Authorization Activity Table (PAAT) for Blexten [2018-12-12]
Post-Authorization Activity Table (PAAT) for Forxiga [2018-12-12]
Post-Authorization Activity Table (PAAT) for Iclusig [2018-12-12]
Post-Authorization Activity Table (PAAT) for Intuniv XR [2018-12-12]
Post-Authorization Activity Table (PAAT) for Istodax [2018-12-12]
Post-Authorization Activity Table (PAAT) for Kisqali [2018-12-12]
Post-Authorization Activity Table (PAAT) for Otezla [2018-12-12]
Post-Authorization Activity Table (PAAT) for Rapivab [2018-12-12]
Post-Authorization Activity Table (PAAT) for Tecfidera [2018-12-12]
Post-Authorization Activity Table (PAAT) for Uptravi [2018-12-12]
Post-Authorization Activity Table (PAAT) for Zerbaxa [2018-12-12]
Notice of Compliance (NOC) Data Extracts [2018-12-07]
Regulatory Decision Summary for Biktarvy [2018-12-05]
Regulatory Decision Summary for Cimzia [2018-12-05]
Post-Authorization Activity Table (PAAT) for Diacomit [2018-12-05]
Regulatory Decision Summary for Faslodex [2018-12-05]
Regulatory Decision Summary for Genvoya [2018-12-05]
Regulatory Decision Summary for KamRAB [2018-12-05]
Regulatory Decision Summary for Radicava [2018-12-05]
Regulatory Decision Summary for Restasis Multidose [2018-12-05]
Regulatory Decision Summary for Rydapt [2018-12-05]
Summary Basis of Decision (SBD) for Panhematin [2018-12-05]
Summary Basis of Decision (SBD) for Monoferric [2018-12-05]
DPD Extracts [2018-12-03]

November

Notice - Validation rules for regulatory transactions submitted to Health Canada in the electronic Common Technical Document (eCTD) format [2018-11-30]
Updated: Notice - Revision to the Post-Notice of Compliance (NOC) Changes - Notices of Change: Level III Form [2018-11-30]
Notice - PDL Amendment - Human and Veterinary Antimicrobials [2018-11-30]
Notice: Validation rules for regulatory transactions provided to Health Canada in the "non-eCTD electronic-only" format [2018-11-30]
Updated List of Drugs for an Urgent Public Health Need [2018-11-30]
Notice of Compliance (NOC) Data Extracts [2018-11-30]
Notice of Intent for the Veterinary Drugs Regulatory Enrolment Process (REP) -Pilot Project [2018-11-28]
Regulatory Enrolment Process [2018-11-28]
TPD Quarterly Drug Submission Performance report for July - September 2018 [2018-11-26]
Updated List of Drugs for an Urgent Public Health Need [2018-11-26]
Generic submissions under review (GSUR) [2018-11-23]
Drug and health product submissions under review (SUR) [2018-11-23]
Notice of Compliance (NOC) Data Extracts [2018-11-23]
Summary Basis of Decision (SBD) for Biktarvy [2018-11-21]
Summary Basis of Decision (SBD) for Eucrisa [2018-11-21]
Regulatory Decision Summary for Duavive [2018-11-21]
Regulatory Decision Summary for Mekinist [2018-11-21]
Regulatory Decision Summary for Repatha [2018-11-21]
Regulatory Decision Summary for Signifor LAR [2018-11-21]
Regulatory Decision Summary for Tafinlar [2018-11-21]
Regulatory Decision Summary for Venclexta [2018-11-21]
Regulatory Decision Summary for Xeljanz [2018-11-21]
Qualifying Notice - Folotyn [2018-11-20]
Register of Innovative Drugs [2018-11-19]
Product Monograph Brand Safety Updates - October 2018 [2018-11-14]
Notice of Compliance (NOC) Data Extracts [2018-11-16]
Notice - Health Canada's efforts to support innovative human therapeutic products to combat antimicrobial resistance (AMR) [2018-11-15]
Product Monograph Brand Safety Updates - October 2018 [2018-11-14]
Notice of Compliance (NOC) Data Extracts [2018-11-09]
Register of Innovative Drugs [2018-11-09]
Updated Register of Certificates of Supplementary Protection and Applications [2018-11-08]
Updated List of Drugs for an Urgent Public Health Need [2018-11-08]
Implementation of ICH Guidance Document E2D: Health Canada Regional Guidance Document for Industry - Reporting Adverse Reactions to Marketed Health Products [2018-11-07]
Notice: ICH E9(R1) Addendum Training Module Now Available [2018-11-07]
Submissions Under Review [2018-10-31]
Regulatory Decision Summary for Alunbrig [2018-11-06]
Regulatory Decision Summary for Bydureon [2018-11-06]
Regulatory Decision Summary for Dotarem [2018-11-06]
Regulatory Decision Summary for Fucibet [2018-11-06]
Regulatory Decision Summary for Galexos [2018-11-06]
Regulatory Decision Summary for Juluca [2018-11-06]
Regulatory Decision Summary for Lovenox and Lovenox HP [2018-11-06]
Regulatory Decision Summary for Mar-Cidofovir [2018-11-06]
Regulatory Decision Summary for Mezera [2018-11-06]
Regulatory Decision Summary for Multihance [2018-11-06]
Regulatory Decision Summary for Nucala [2018-11-06]
Regulatory Decision Summary for Symtuza [2018-11-06]
Regulatory Decision Summary for Tivicay [2018-11-06]
Regulatory Decision Summary for Triumeq [2018-11-06]
Summary Basis of Decision (SBD) for MVASI [2018-11-06]
Notice of Compliance (NOC) Data Extracts [2018-11-02]
DPD Extracts [2018-11-01]
Notice: Prescription Drug List (PDL): Multiple additions [2018-11-01]

October

Scientific Advisory Committee On Respiratory and Allergy Therapies (SAC-RAT) - Record of Proceedings for February 23, 2018[2018-10-24]
Scientific Advisory Committee On Respiratory and Allergy Therapies (SAC-RAT) - November 11, 2018 Meeting Announcement and Agenda [2018-10-24]
Data Requirements for Safety and Effectiveness of Subsequent Entry Inhaled Corticosteroid Products Used for the Treatment of Asthma [2018-10-31]
National Association of Pharmacy Regulatory Authorities (NAPRA), 2017-10-19 [2018-10-30]

Register of Innovative Drugs [2018-10-26]
Notice of Compliance (NOC) Data Extracts [2018-10-26]
Consultation on proposed revisions to the Guidance Document: Management of Drug Submissions [2018-10-25]
National Association of Pharmacy Regulatory Authorities (NAPRA), 2016-09-23 [2018-10-23]
Notice of Compliance (NOC) Data Extracts [2018-10-19]
Updated Register of Certificates of Supplementary Protection and Applications [2018-10-19]
Final Record of Decisions - October 24, 2016, Meeting with Innovative Medicines Canada (IMC) [2018-10-18]
Final Record of Decisions - April 20, 2017, Meeting with Innovative Medicines Canada (IMC) [2018-10-18]
Final Record of Decisions - October 5, 2017, Meeting with Innovative Medicines Canada (IMC) [2018-10-18]
Product Monograph Brand Safety Updates - September 2018 [2018-10-17]

Notice of Amendment: Prescription Drug List (PDL): Phytocannabinoids [2018-10-17]
Post-Authorization Activity Table (PAAT) for Adcetris [2018-10-16]
Post-Authorization Activity Table (PAAT) for Iclusig [2018-10-16]
Regulatory Decision Summary for Imbruvica [2018-10-16]
Post-Authorization Activity Table (PAAT) for Jardiance [2018-10-16]
Summary Basis of Decision (SBD) for Kisqali [2018-10-16]
Summary Basis of Decision (SBD) for Lapelga [2018-10-16]
Post-Authorization Activity Table (PAAT) for Lartruvo [2018-10-16]
Regulatory Decision Summary for Maviret [2018-10-16]
Post-Authorization Activity Table (PAAT) for MDK-Nitisinone [2018-10-16]
Summary Basis of Decision (SBD) for Rekovelle [2018-10-16]
Summary Basis of Decision (SBD) for Steglatro [2018-10-16]
Regulatory Decision Summary for Stivarga [2018-10-16]
Regulatory Decision Summary - Tresiba [2018-10-16]
Notice of Compliance (NOC) Data Extracts [2018-10-12]
Register of Innovative Drugs [2018-10-11]
Consultation : Release of Draft (Step 2) ICH Guidance: S11: Nonclinical Safety Testing in Support of Development of Paediatric Medicines [2018-10-10]
Regulatory Decision Summary for Apo-desvenlafaxine [2018-10-09]
Regulatory Decision Summary for AA-clozapine [2018-10-09]
Regulatory Decision Summary for Soliqua [2018-10-09]
Regulatory Decision Summary for Lynparza (Control no. 205344) [2018-10-09]
Regulatory Decision Summary for Lynparza (Control no. 210204) [2018-10-09]
Regulatory Decision Summary for Kymriah (Control no. 213698) [2018-10-09]
Regulatory Decision Summary for Kymriah (Control no. 213547) [2018-10-09]
Regulatory Decision Summary for Imbruvica [2018-10-09]
Regulatory Decision Summary for Olumiant [2018-10-09]
Regulatory Decision Summary for Rayaldee [2018-10-09]
Regulatory Decision Summary for Keytruda [2018-10-09]
Post-Authorization Activity Table (PAAT) for Imfinzi [2018-10-09]
Post-Authorization Activity Table (PAAT) for Invokana [2018-10-09]
Summary Basis of Decision (SBD) for Symdeko [2018-10-09]
Notice of Compliance (NOC) Data Extracts [2018-10-05]
Notice: Regulatory Enrolment Process (REP) Pilot for Human Drugs (Division 1 and 8) Transactions [2018-10-04]
Updated Register of Certificates of Supplementary Protection and Applications [2018-10-01]
Notice of Amendment: Prescription Drug List (PDL): Hydroquinone [2018-10-01]
Notice: Prescription Drug List (PDL): Multiple additions [2018-10-01]
Notice to Stakeholders - Opioid warning sticker and patient information handout requirements come into force on October 20, 2018 [2018-10-01]
Regulatory Decision Summary for PMS-Fluoxetine [2018-10-01]
Regulatory Decision Summary for Velphoro [2018-10-01]
Regulatory Decision Summary for Ultibro Breezhaler [2018-10-01]
Regulatory Decision Summary for Steglatro [2018-10-01]
Regulatory Decision Summary for Fycompa [2018-10-01]
Regulatory Decision Summary for Bevespi Aerosphere [2018-10-01]
Regulatory Decision Summary for Banzel [2018-10-01]
Regulatory Decision Summary for APO-Desvenlafaxine [2018-10-01]
Regulatory Decision Summary for Abilify Maintena [2018-10-01]
Regulatory Decision Summary for Aptiom [2018-10-01]
Regulatory Decision Summary for Eucrisa [2018-10-01]
Regulatory Decision Summary for Contrave [2018-10-01]
DPD Extracts [2018-10-01]

September

Notice of Compliance (NOC) Data Extracts [2018-09-28]
Notice of Compliance (NOC) Data Extracts [2018-09-21]
Product Monograph Brand Safety Updates - August 2018 [2018-09-21]
Submissions Under Review [2018-09-21]
Updated Register of Certificates of Supplementary Protection and Applications [2018-09-18]
Notice of Compliance (NOC) Data Extracts [2018-09-14]
Updated List of Drugs for an Urgent Public Health Need [2018-09-11]
Post-Authorization Activity Table (PAAT) for Tivicay [2018-09-11]
Post-Authorization Activity Table (PAAT) for Eloctate [2018-09-11]
Post-Authorization Activity Table (PAAT) for Durezol [2018-09-11]
Post-Authorization Activity Table (PAAT) for Bavencio [2018-09-11]
Post-Authorization Activity Table (PAAT) for Spinraza [2018-09-11]
Regulatory Decision Summary for Panhematin [2018-09-11]
Regulatory Decision Summary for Aimovig [2018-09-11]
Regulatory Decision Summary for Repatha [2018-09-11]
Regulatory Decision Summary for Harvoni [2018-09-11]
Regulatory Decision Summary for Bexsero [2018-09-11]
Regulatory Decision Summary for Nuceiva [2018-09-11]
Regulatory Decision Summary for Soliris [2018-09-11]
Regulatory Decision Summary for Monoferric [2018-09-07]
Regulatory Decision Summary for HADLIMA, HADLIMA PushTouch [2018-09-07]
Regulatory Decision Summary for Ibrance [2018-09-07]
Regulatory Decision Summary for Penthrox [2018-09-07]
Regulatory Decision Summary for Gazyva [2018-09-07]
Regulatory Decision Summary for Erleada [2018-09-07]
Regulatory Decision Summary for Hemlibra [2018-09-07]
Summary of Cancellation: Human heterologous liver cells, HHLivC (HepaBridge) (Control number 205160) [2018-09-07]
Post-Authorization Activity Table (PAAT) for Forxiga [2018-09-07]
Post-Authorization Activity Table (PAAT) for Mekinist [2018-09-07]

August

DPD Extracts [2018-09-04]
Notice: Publication of Update to the Guidance Document: Certificate of Supplementary Protection Regulations [2018-09-04]
Notice of Compliance (NOC) Data Extracts [2018-08-31]
Register of Innovative Drugs [2018-08-31]
Submissions Under Review [2018-08-30]
Updated Register of Certificates of Supplementary Protection and Applications [2018-08-29]
Summary Basis of Decision (SBD) for Erleada [2018-08-27]
Updated - Notice regarding the Post-Notice of Compliance (NOC) Changes – Notices of Change: Level III Form [2018-08-27]
Notice of Compliance (NOC) Data Extracts [2018-08-24]
TPD Quarterly Drug Submission Performance report for April - June 2018 [2018-08-24]
Notice: Prescription Drug List (PDL): Nicotine Qualifier Clarification [2018-08-23]
Regulatory Decision Summary for Opdivo [2018-08-22]
Regulatory Decision Summary for Arbesda Respiclick [2018-08-22]
Regulatory Decision Summary for Hizentra [2018-08-22]
Regulatory Decision Summary for Zykadia [2018-08-22]
Regulatory Decision Summary for Trelegy Ellipta [2018-08-22]
Regulatory Decision Summary for Monoferric [2018-08-22]
Post-Authorization Activity Table (PAAT) for Imbruvica [2018-08-22]
Post-Authorization Activity Table (PAAT) for Lenvima [2018-08-22]
Post-Authorization Activity Table (PAAT) for Remsima [2018-08-22]
Post-Authorization Activity Table (PAAT) for Praxbind [2018-08-22]
Summary Basis of Decision (SBD) for Besponsa [2018-08-22]
Summary Basis of Decision (SBD) for HADLIMA / HADLIMA PUSHTOUCH [2018-08-20]
Notice: Phase III of Pre-Market Transparency Initiatives for Prescription Drugs [2018-08-03]
Notice of Compliance (NOC) Data Extracts [2018-08-17]
Notice: Prescription Drug List (PDL): Multiple Additions [2018-08-16]
Updated Register of Certificates of Supplementary Protection and Applications [2018-08-16]
Register of Innovative Drugs [2018-08-16]
Product Monograph Brand Safety Updates – July 2018 [2018-08-14]
Post-Authorization Activity Table (PAAT) for Mictoryl/Mictoryl Pediatric [2018-08-13]
Post-Authorization Activity Table (PAAT) for Sovaldi [2018-08-13]
Post-Authorization Activity Table (PAAT) for Alprolix [2018-08-13]
Post-Authorization Activity Table (PAAT) for Istodax [2018-08-13]
Summary of Cancellation for AVASTIN (Control number 207217) [2018-08-13]
Regulatory Decision Summary for Avastin [2018-08-13]
Regulatory Decision Summary for Tafinlar [2018-08-13]
Regulatory Decision Summary for Steglujan [2018-08-13]
Regulatory Decision Summary for Probuphine [2018-08-13]
Summary Basis of Decision (SBD) for Probuphine [2018-08-13]
Regulatory Decision Summary for Foquest [2018-08-13]
Regulatory Decision Summary for Ikervis [2018-08-13]
Updated Register of Certificates of Supplementary Protection and Applications [2018-08-10]
Notice of Compliance (NOC) Data Extracts [2018-08-10]
Updated List of Drugs for an Urgent Public Health Need [2018-08-10]
Consultation: Release of Draft (Step 2) ICH M9 Guidance: Biopharmaceutics Classification System-based Biowavers [2018-08-08]
Qualifying Notice – Alunbrig [2018-08-03]
Updated Register of Certificates of Supplementary Protection and Applications [2018-08-03]
DPD Extracts [2018-08-01]

July

Register of Innovative Drugs [2018-07-30]
Notice of Compliance (NOC) Data Extracts [2018-07-27]
Updated Register of Certificates of Supplementary Protection and Applications [2018-07-25]
Notice: Prescription Drug List (PDL): Multiple additions [2018-07-25]
Submissions Under Review [2018-07-23]
Updated List of Drugs for an Urgent Public Health Need [2018-07-23]
Notice of Compliance (NOC) Data Extracts [2018-07-20]
Register of Innovative Drugs [2018-07-20]
Regulatory Decision Summary for Imbruvica [2018-07-17]
Post-Authorization Activity Table (PAAT) for Viibryd [2018-07-17]
Post-Authorization Activity Table (PAAT) for Lixiana [2018-07-17]
Post-Authorization Activity Table (PAAT) for Lonsurf [2018-07-17]
Post-Authorization Activity Table (PAAT) for Epclusa [2018-07-17]
Post-Authorization Activity Table (PAAT) for Sunvepra [2018-07-17]
Post-Authorization Activity Table (PAAT) for Akynzeo [2018-07-17]
Post-Authorization Activity Table (PAAT) for Daklinza [2018-07-17]
Regulatory Decision Summary for Segluromet [2018-07-17]
Post-Authorization Activity Table (PAAT) for Eloctate [2018-07-17]
Post-Authorization Activity Table (PAAT) for DaTscan [2018-07-17]
Product Monograph Brand Safety Updates [2018-07-16]
Notice: Australia Canada Singapore Switzerland (ACSS) Consortium – Approval of Erleada [2018-07-13]
Notice of Compliance (NOC) Data Extracts [2018-07-13]
Notifying Health Canada of Foreign Actions - Guidance Document for Industry - Summary [2018-07-12]
Notice of Intent to Amend: Prescription Drug List (PDL): Phytocannabinoids [2018-07-11]
Therapeutic Products Directorate Statistical Report 2017/2018 [2018-07-11]
Notice: 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 [2018-07-10]
Notice of Compliance (NOC) Data Extracts [2018-07-06]
Summary of Cancellation: lorcaserin hydrochloride (*Belviq) [2018-07-06]
Post-Authorization Activity Table (PAAT) for Galafold [2018-07-06]
Post-Authorization Activity Table (PAAT) for Fasenra [2018-07-06]
Post-Authorization Activity Table (PAAT) for Xiidra [2018-07-06]
Post-Authorization Activity Table (PAAT) for Shingrix [2018-07-06]
Post-Authorization Activity Table (PAAT) for Zontivity [2018-07-06]
Post-Authorization Activity Table (PAAT) for Lonsurf [2018-07-06]
Qualifying Notice – Opdivo [2018-07-05]
Regulatory Decision Summary for Latuda [2018-07-05]
Post-Authorization Activity Table (PAAT) for Tremfya [2018-07-05]
Post-Authorization Activity Table (PAAT) for Renflexis [2018-07-05]
Post-Authorization Activity Table (PAAT) for Rupall (Formerly Rupatadine) [2018-07-05]
Post-Authorization Activity Table (PAAT) for Fetzima [2018-07-05]
Notice: Prescription Drug List (PDL): Multiple Additions [2018-07-04]

June

DPD Extracts [2018-07-03]
Register of Innovative Drugs [2018-06-29]
Notice of Compliance (NOC) Data Extracts [2018-06-29]
Updated Register of Certificates of Supplementary Protection and Applications [2018-06-28]
Summary Basis of Decision (SBD) for SILIQ [2018-06-29]
Post-Authorization Activity Table (PAAT) for Brinavess [2018-06-29]
Post-Authorization Activity Table (PAAT) for Dupixent [2018-06-29]
Post-Authorization Activity Table (PAAT) for Kanuma [2018-06-29]
Post-Authorization Activity Table (PAAT) for Ozanex [2018-06-29]
Post-Authorization Activity Table (PAAT) for Ozempic [2018-06-29]
Post-Authorization Activity Table (PAAT) for Rebinyn [2018-06-29]
Post-Authorization Activity Table (PAAT) for Erelzi [2018-06-29]
Regulatory Decision Summary for Dysport Aesthetic [2018-06-29]
Regulatory Decision Summary for Mvasi [2018-06-29]
Regulatory Decision Summary for Siliq [2018-06-29]
Regulatory Decision Summary for Imfinzi [2018-06-29]
Regulatory Decision Summary for Xgeva [2018-06-29]
Regulatory Decision Summary for Alphanate [2018-06-29]
Post-Authorization Activity Table (PAAT) for Maviret [2018-06-29]
Post-Authorization Activity Table (PAAT) for Procysbi [2018-06-29]
Post-Authorization Activity Table (PAAT) for Eperzan [2018-06-29]
Post-Authorization Activity Table (PAAT) for Prevymis [2018-06-29]
Post-Authorization Activity Table (PAAT) for Nesina [2018-06-29]
Post-Authorization Activity Table (PAAT) for Forxiga [2018-06-29]
Post-Authorization Activity Table (PAAT) for Aubagio [2018-06-29]
Post-Authorization Activity Table (PAAT) for Saflutan [2018-06-29]
Submissions Under Review [2018-06-28]
Notice - Release of the revised Notice regarding the Post-Notice of Compliance (NOC) Changes – Notices of Change: Level III Form [2018-06-26]
Notice: Release of the revised Guidance Document: Post-Notice of Compliance (NOC) Changes - Safety and Efficacy [2018-06-26]
Notice: Release of the revised Post-Notice of Compliance (NOC) Changes - Framework Guidance Document [2018-06-26]
Notice: Release of Draft (Step 2) ICH Guidance: Q3D(R1): Revision of Cadmium Inhalation PDE [2018-06-26]
Radiopharmaceuticals, Kits, and Generators - Submission Information for Schedule C Drugs: Draft Guidance Document for Consultation [2018-06-26]
Notice: Step 4 - ICH S9 Guideline: Nonclinical Evaluation for Anticancer Pharmaceuticals, Questions and Answers [2018-06-26]
Notice to industry: Aligned reviews between Health Canada and health technology assessment organizations [2018-06-22]
Register of Innovative Drugs [2018-06-22]
Updated Register of Certificates of Supplementary Protection and Applications [2018-06-22]
Notice of Compliance (NOC) Data Extracts - June 22, 2018 [2018-06-22]
Updated List of Drugs for an Urgent Public Health Need [2018-06-21]
TPD/BGTD/NNHPD Quarterly Drug Submission Performance report for Q4-2017-2018 and TPD/BGTD/NNHPD Annual Drug Submission Performance report for 2017-2018 [2018-06-15]
Register of Innovative Drugs [2018-06-15]
Notice of Compliance (NOC) Data Extracts - June 15, 2018 [2018-06-15]
Updated List of Drugs for an Urgent Public Health Need [2018-06-14]
Product Monograph Brand Safety Updates - May 2018 [2018-06-13]
Register of Innovative Drugs [2018-06-13]
Guidance Document - Fees for the Right to Sell Drugs [2018-06-12]
Summary - Guidance Document: Cancellation of a Drug Identification Number (DIN) and Notification of Discontinuation of Sales [2018-06-12]
Qualifying Notice - Imfinzi [2018-06-08]
Notice of Compliance (NOC) Data Extracts - June 8, 2018 [2018-06-08]
Updated Register of Certificates of Supplementary Protection and Applications [2018-06-07]
Notice: Health Canada Review of Vitamin D Levels for Non-Prescription Use [2018-06-04]
DPD Extracts [2018-06-01]
Qualifying Notice - Bavencio [2018-05-31]
Notice of Compliance (NOC) Data Extracts - June 1, 2018 [2018-06-01]
Post-Authorization Activity Table (PAAT) for Ocrevus [2018-06-01]
Post-Authorization Activity Table (PAAT) for Defitelio [2018-06-01]
Post-Authorization Activity Table (PAAT) for Tresiba [2018-06-01]
Post-Authorization Activity Table (PAAT) for Vosevi [2018-06-01]
Post-Authorization Activity Table (PAAT) for Ocaliva [2018-06-01]
Regulatory Decision Summary for OPDIVO [2018-06-01]
Regulatory Decision Summary for BAVENCIO [2018-06-01]
Regulatory Decision Summary for XULTOPHY [2018-06-01]

May

Summary Basis of Decision (SBD) for ADDYI [2018-05-03]
Register of Innovative Drugs [2018-05-25]
Notice of Compliance (NOC) Data Extracts – May 25, 2018 [2018-05-25]
Product Monograph Brand Safety Updates – April 2018 [2018-05-30]
Qualifying Notice for Lynparza [2018-05-23]
Notice of Compliance (NOC) Data Extracts – May 18, 2018 [2018-05-18]
Notice: Revision of Guidance documents: Conduct and Analysis of Comparative Bioavailability Studies & Comparative Bioavailability Standards: Formulations used for Systemic Effects [2018-05-16]
Updated: Guidance Document: Patented Medicines (Notice of Compliance Regulations [2018-05-11]
Updated: Patent Register – Frequently Asked Questions [2018-05-11]
Updated Prescription Drug List (PDL) [2018-05-11]
Notice of Compliance (NOC) Data Extracts - May 11, 2018 [2018-05-11]
Regulatory Decision Summary for ADDYI [2018-05-10]
Regulatory Decision Summary for Lapelga [2018-05-10]
Regulatory Decision Summary for Norditropin NordiFlex [2018-05-10]
Submissions Under Review [2018-05-10]
Post-Authorization Activity Table (PAAT) for Adlyxine [2018-05-10]
Post-Authorization Activity Table (PAAT) for Viberzi [2018-05-09]
Post-Authorization Activity Table (PAAT) for Venclexta [2018-05-09]
Post-Authorization Activity Table (PAAT) for Cerdelga [2018-05-09]
Post-Authorization Activity Table (PAAT) for Lancora [2018-05-09]
Post-Authorization Activity Table (PAAT) for Rexulti [2018-05-09]
Post-Authorization Activity Table (PAAT) for Nitisinone Tablets [2018-05-08]
Post-Authorization Activity Table (PAAT) for Ninlaro [2018-05-07]
Consultation for Mandatory Requirements of using Electronic Common Technical Document (eCTD) Format when Submitting Master Files (MFs) [2018-05-07]
Notice of Compliance (NOC) Data Extracts – May 4, 2018 [2018-05-04]
Notice: Medical Device Single Audit Program (MDSAP) Reduction of Audit Times for Small-sized Enterprises – update [2018-05-04]
Warning Sticker and Opioid Patient Information Handout [2018-05-02]
Access to Generic Drugs in Canada [2018-05-02]
Regulatory Decision Summary for Jaydess [2018-05-02]
Regulatory Decision Summary for Simponi I.V. [2018-05-02]
Regulatory Decision Summary for Kisqali [2018-05-02]
Regulatory Decision Summary for Tecentriq [2018-05-02]
Regulatory Decision Summary for Taltz [2018-05-02]
Regulatory Decision Summary for Rituxan SC [2018-05-02]
Regulatory Decision Summary for Rekovelle [2018-05-02]
DPD Extracts [2018-05-01]

April

Summary Basis of Decision (SBD) for DATSCAN [2018-04-30]
Summary Basis of Decision (SBD) for FASENRA [2018-04-30]
Notice to Industry: ACSS - New Chemical Entities Work Sharing Trial Phase I [2018-04-30]
Notice of Compliance (NOC) Data Extracts [2018-04-27]
Updated Register of Certificates of Supplementary Protection and Applications [2018-04-27]
ICH S3A Questions and Answers: Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure – Focus on Microsampling [2018-04-26]
Register of Innovative Drugs [2018-04-26]
ICH M7(R1): Genotoxic Impurities - Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk [2018-04-26]
ICH E18: Genomic Sampling and Management of Genomic Data [2018-04-26]
What We Heard - Proposals for prescription drug transparency [2018-04-25]
Updated Register of Certificates of Supplementary Protection and Applications [2018-04-24]
Regulatory Decision Summary for GLYXAMBI [2018-04-20]
Register of Innovative Drugs [2018-04-20]
Regulatory Decision Summary for Dysport Therapeutic [2018-04-20]
Regulatory Decision Summary for Besponsa [2018-04-20]
Final Notice - Classification of Dental Plaque-disclosing Products as Drugs [2018-04-18]
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]
Regulatory Decision Summary for Prevymis [2018-04-17]
Regulatory Decision Summary for Blincyto [2018-04-17]
Regulatory Decision Summary for Orencia [2018-04-17]
Updated Register of Certificates of Supplementary Protection and Applications [2018-04-13]
Notice of Compliance (NOC) Data Extracts [2018-04-13]
Submissions Under Review [2018-04-13]
Product Monograph Brand Safety Updates – March 2018 [2018-04-10]
Regulatory Decision Summary for Sitavig [2018-04-10]
Regulatory Decision Summary for Auro-Cefixime [2018-04-10]
Regulatory Decision Summary for Xiidra [2018-04-10]
Regulatory Decision Summary for Cuvposa [2018-04-10]
Regulatory Decision Summary for Afluria Tetra [2018-04-10]
Scientific Advisory Panel on Isotretinoin Risk Management (SAP-IRM) - Membership and Biographies; Summary of Expertise, Experience and Affiliations and Interests; Record of Proceedings [2018-04-06]
Register of Innovative Drugs [2018-04-06]
Summary Basis of Decision (SBD) for Lonsurf [2018-04-06]
Updated Register of Certificates of Supplementary Protection and Applications [2018-04-06]
Notice of Compliance (NOC) Data Extracts – April 6, 2018 [2018-04-06]
ICH E11(R1) Addendum: Clinical Investigation of Medicinal Products in the Pediatric Population [2018-04-05]
Summary Basis of Decision (SBD) for Ozempic [2018-04-04]
ICH Q11: Questions and Answers: Selection and Justification of Starting Materials for the Manufacture of Drug Substances [2018-04-04]
DPD Extracts [2018-04-03]
Register of Innovative Drugs [2018-04-03]

March

Notice of Compliance (NOC) Data Extracts - March 29, 2018 [2018-03-29]
Notice: eCTD Pilot for Clinical Trial Regulatory Activities – Extension [2018-03-28]
Summary Basis of Decision (SBD) for Tremfya [2018-03-23]
Notice of Compliance (NOC) Data Extracts – March 23, 2018 [2018-03-23]
Register of Innovative Drugs [2018-03-23]
Product Monograph Brand Safety Updates - February 2018 [2018-03-23]
Regulatory Decision Summary for Ixiaro [2018-03-20]
Summary of Cancellation for Nivolumab (Opdivo) [2018-03-20]
Regulatory Decision Summary for Cutaquig [2018-03-20]
Regulatory Decision Summary for Fasenra [2018-03-20]
Regulatory Decision Summary for Zytiga [2018-03-20]
Updated Register of Certificates of Supplementary Protection and Applications [2018-03-20]
Submissions Under Review [2018-03-20]
New Drug Submission – Application Fee Form for Human and Disinfectant Drugs for submissions filed on or after April 1^st, 2018 [2018-03-16]
New Master File Applications Fee Form for Human Drugs for filing on or after April 1^st, 2018 [2018-03-16]
Notice of Compliance (NOC) Data Extracts – March 16, 2018 [2018-03-16]
Register of Innovative Drugs [2018-03-15]
Post-Authorization Activity Table (PAAT) for Brenzys [2018-03-13]
Post-Authorization Activity Table (PAAT) for Cinqair [2018-03-13]
Regulatory Decision Summary for Ocrevus [2018-03-13]
Regulatory Decision Summary for Prolia [2018-03-13]
Regulatory Decision Summary for Xiaflex [2018-03-13]
Summary Basis of Decision (SBD) for Velphoro [2018-03-12]
Notice - Prescription Drug List (PDL): Multiple Additions [2018-03-12]
Summary Basis of Decision (SBD) for Bavencio [2018-03-09]
Notice of Compliance (NOC) Data Extracts – March 9, 2018 [2018-03-09]
Updated Register of Certificates of Supplementary Protection and Applications [2018-03-09]
TPD Quarterly Drug Submission Performance report for Q3-2017-2018 [2018-03-02]
Notice of Compliance (NOC) Data Extracts – March 2, 2018 [2018-03-02]
Notice: Release of Draft (Step 2) ICH Guidance: Q12: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management [2018-03-02]
DPD Extracts [2018-03-01]

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