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New Guidance on Off-Label drug benefits in trials: Health Canada


17th June 2019

The agency, Health Canada, issued guidance to study the off-label uses of different drugs in clinical trials.

According to the current regulations from Health Canada, the drugs purchased for clinical trials for their off-label benefits to be designated as “investigational drugs”.

Under new guidelines, any given treatment from sponsors will go through a series of questions from Canadian officials before getting the “investigational drug tag”. Following questions can be asked:

· Is the safety profile established for the drug when used off-label; · For what measures, it is used in clinical trials; · Is there any risks and benefits related to off-label use of drugs; · Is the drug registration already done in Canada; · Will the trial doses be bought in Canada; and · Does the off-label use increase chances of fatal risks.

The off-label drug’s compliance notice or Drug Identification number needs to be submitted by the sponsor and explanation for its original indication is also given.


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