Health

Notice: Validation rules for regulatory transactions provided to Health Canada in the “non-eCTD electronic-only” format

The validation rules build on the information provided in the Guidance Document: Preparation of Regulatory Activities in “Non-eCTD Electronic-Only” format and if used accurately, will enable sponsors to ensure their transactions are processed efficiently without encountering delays resulting from validation failure.

 
 

Product Monograph Brand Safety Updates July 2017

Product Monograph Brand Safety Updates for Submissions Cleared between 01-07-2017 and 31-07-2017.

 
 

Consultation on Proposed Modification to Bioequivalence Standards for Multiphasic Modified-Release Drug Products

Notice on proposed modification to bioequivalence standards for multiphasic modified-release drug products.

 
 

Regulatory Decision Summary for EMEND IV (Control number 197185)

Regulatory Decision Summaries (RDSs) explain Health Canada’s decisions for certain health products seeking market authorization.

 
 

Regulatory Decision Summary for PROLASTIN-C (Control number 205855)

Regulatory Decision Summaries (RDSs) explain Health Canada’s decisions for certain health products seeking market authorization.

 
 

Regulatory Decision Summary for BELBUCA (Control number 196428)

Regulatory Decision Summaries (RDSs) explain Health Canada’s decisions for certain health products seeking market authorization.

 
 

Updated List of Drugs for an Urgent Public Health Need

Notification of the addition of Priftin (rifapentine) to the Urgent Public Health Need List for import into Newfoundland/Labrador in the treatment of Latent Tuberculosis Infection.

 
 

Submissions Under Review

This is a list of certain drug submissions currently under review. The Submissions Under Review list includes the medicinal ingredient(s) and therapeutic area.

 
 

Summary Basis of Decision for CERDELGA

Health Canada Summary Basis of Decision 2017-07-10 Cerdelga, eliglustat, 84 mg, capsules, Sanofi Genzyme, a division of sanofi-aventis Canada Inc. Submission Control Number 183050

 
 

Post-Authorization Activity Table (PAAT) for RAVICTI

Health Canada Post-Authorization Activity Table 2017-05-03 Ravicti, glycerol phenylbutyrate, 1.1 g/mL,  liquid, Horizon Pharma Ireland Ltd.  

 
 
 
 

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