Health

Publication of the Final Guidance Document: Administrative Processing of Submissions and Applications Involving Human or Disinfectant Drugs

Publication of the Final Guidance Document: Administrative Processing of Submissions and Applications Involving Human or Disinfectant Drugs to clarify the requirements for eligible drug submissions and applications that will be processed under the administrative pathway.

 
 

Product Monograph Brand Safety Updates – November 2017

Product Monograph Brand Safety Updates for Submissions cleared between 01-11-2017 and 30-11-2017

 
 

Updated 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.

 
 

Lartruvo – Notice of Compliance with Conditions – Qualifying Notice

An NOC/c is authorization to market a drug (i.e. a Notice of Compliance (NOC)), with the condition that the sponsor undertake additional studies to verify the clinical benefit. The NOC, qualifying under the NOC/c policy, is issued under section C.08.004 of the Food and Drug Regulations.

 
 

Latruvo – Notice of Compliance with Conditions – Qualifying Notice

An NOC/c is authorization to market a drug (i.e. a Notice of Compliance (NOC)), with the condition that the sponsor undertake additional studies to verify the clinical benefit. The NOC, qualifying under the NOC/c policy, is issued under section C.08.004 of the Food and Drug Regulations.

 
 

Regulatory Decision Summary for NiaStase RT

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

 
 

Regulatory Decision Summary for Lucentis

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

 
 

Regulatory Decision Summary for Anthrasil

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

 
 

Regulatory Decision Summary for Vosevi

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

 
 

Regulatory Decision Summary for Maviret

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

 
 
 
 

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