Canada: Health Canada drafts policies for special access to medicines program

15-05-2019

Canada: Health Canada drafts policies for special access to medicines program

(Source: RAPS 2019-05-13)

Similar to the US Food and Drug Administration’s expanded access program, which allows for those with serious or life-threatening conditions to gain access to experimental medicines, Health Canada opened a draft guidance consultation on changes to its Special Access Program (SAP) for drugs.

The 29-page draft guidance builds on previous guidance adopted in 2014 and explains how Canadian health care practitioners can obtain access to an unauthorized drug for emergency treatment of a serious or life-threatening condition if conventional therapies have failed, are unsuitable or are unavailable either on the market or via clinical trial enrollment.

New to the scope of the SAP guidance is draft information on the process to request a reconsideration review prior to the issuance of a request denial and a personalized service for urgent life-threatening or end-of-life situations. Required conditions for pre-positioning requests are detailed in the draft as well.

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