What's New

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.

2017

September

• How to Pay Fees to Health Products and Food Branch (HPFB) [2017-09-19]
• Notice: Publication of the Guidance Document: Certificate of Supplementary Protection Regulations [2017-09-19]
• Notice – Patented Medicines (Notice of Compliance) Regulations [2017-09-19]
• Regulatory Decision Summary for FRAXIPARINE / FRAXIPARINE FORTE (Control number 195973) [2017-09-12]
• Regulatory Decision Summary for FLEBOGAMMA 5% / FLEBOGAMMA 10% (Control number 194291) [2017-09-12]
• Regulatory Decision Summary for OCREVUS (Control number 198094) [2017-09-12]

August

• Regulatory Decision Summary for DEFITELIO (Control number 200808) [2017-08-30]
• Regulatory Decision Summary for ADCETRIS (Control number 185779) [2017-08-30]
• Regulatory Decision Summary for ENTUZITY (Control number 189076) [2017-08-30]
• Therapeutic Products Directorate (TPD), Biologics and Genetic Therapies Directorate (BGTD), Natural and Non-Prescription Health Products Directorate (NNHPD) Drug Submission Performance Quarterly Reports - April - June 2017 [2017-08-29]

July

• Regulatory Decision Summary for OPDIVO (Control number 99379) [2017-07-13]
• Regulatory Decision Summary for VICTOZA (Control number 196457) [2017-07-13]
• Regulatory Decision Summary for KINERET (Control number 195649) [2017-07-13]
• Regulatory Decision Summary for EYLEA (Control number 186851) [2017-07-13]
• Strengthening the Assisted Human Reproduction Act [2017-07-12]
• Post-Authorization Activity Table for GARDASIL 9 [2017-07-12]

June

• Updates to the Prescription Drug List [2017-06-23]
• Updated: Questions and Answers for the Guidance for Industry: Preparation of Drug Submissions in the eCTD Format [2017-06-29]
• Access to Drugs in Exceptional Circumstances [2017-06-28]
• Regulatory decision summary for UTROGESTAN (Control number 180004) [2017-06-06]
• Regulatory decision summary for XOLAIR (Control number 194542) [2017-06-06]
• Post-Authorization Activity Table for PRAXBIND [2017-06-06]
• Post-Authorization Activity Table for VIMIZIM [2017-06-06]
• Regulatory decision summary for YERVOY (Control number 202533) [2017-06-06]
• Post-Authorization Activity Table for OPDIVO [2017-06-06]
• Post-Authorization Activity Table for XOFIGO [2017-06-06]
• Regulatory decision summary for PORTRAZZA (Control number 193689) [2017-06-06]
• Post-Authorization Activity Table for PRALUENT [2017-06-06]
• Post-Authorization Activity Table for DARZALEX [2017-06-06]

May

• Updates to the Prescription Drug List [2017-05-19]
• Summary Basis of Decision for PORTRAZZA [2017-05-16]
• Notice to Stakeholders: Release of the Product Monograph Template - Schedule D - Biosimilar Biologic Drug [2017-05-15]
• Post-Authorization Activity Table for ELELYSO [2017-05-08]
• Post-Authorization Activity Table for ENTYVIO [2017-05-03]
• Regulatory decision summary for ERELZI (Control number 193864) [2017-05-03]
• Post-Authorization Activity Table for NUWIQ [2017-05-03]
• Regulatory decision summary for BERINERT 500/ BERINERT 1500 (Control number 197440) [2017-05-03]
• Regulatory decision summary for DARZALEX (Control number 198647) [2017-05-02]
• Updated Master File (MF) Application Fee Form For Human Drugs [2017-05-01]
• Post-Authorization Activity Table for ZEPATIER [2017-05-01]

April

• Notice: Release of the Final Guidance Document: Master Files (MFs) - Procedures and Administrative Requirements [2017-04-28]
• Notice - Mandatory use of the Electronic Common Technical Document (eCTD) format [2017-04-24]
• Notice of Compliance with Conditions - Qualifying Notice for Tecentriq [2017-04-24]
• Updates to the Prescription Drug List [2017-04-21]
• Regulatory decision summary for REXULTI (Control number 192684) [2017-04-21]
• Summary Basis of Decision for NEURACEQ [2017-04-18]
• Notice - Intellectual Property Hold for Notifiable Change Submissions [2017-04-07]
• Regulatory decision summary for ENBREL (Control number 193787) [2017-04-07]
• Regulatory decision summary for REPLAGAL (Control number 188407) [2017-04-06]

March

• Notice: Availability of Summary Basis of Decision Documents and Regulatory Decision Summaries on the Drug and Health Products Register [2017-03-29]
• Updates to the Prescription Drug List [2017-03-29]
• Notice: Guidance Document - Fees for the Right to Sell Drugs [2017-03-14]
• Regulatory decision summary for ONCASPAR (Control number 189795) [2017-03-10]
• Summary Basis of Decision for KEVZARA [2017-03-09]

February

• Regulatory Decision Summary for CUVITRU (Control number 190451) [2017-02-28]
• Regulatory decision summary for EVICEL (Control number 178389) [2017-02-17]
• Regulatory Decision Summary for OBIZUR (Control number 177290) [2017-02-16]
• Summary Basis of Decision for AFSTYLA [2017-02-10]
• Updates to the Prescription Drug List [2017-02-10]
• Regulatory decision summary for AFSTYLA (Control number 190891) [2017-02-02]
• Updates to the Prescription Drug List [2017-02-02]

January

• Post-Authorization Activity for STRENSIQ [2017-01-31]
• Post-Authorization Activity for EPERZAN [2017-01-31]
• Regulatory Decision Summary for GAZYVA (Control number 191269) [2017-01-27]
• Regulatory Decision Summary for ILARIS (Control number 195617) [2017-01-26]
• Regulatory Decision Summary for FIASP (Control number 191494) [2017-01-25]
• Regulatory decision summary for KEVZARA (Control number 191745) [2017-01-25]
• Summary Basis of Decision for ADYNOVATE [2017/01/06]