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20 June 2018
On December 9 2017 Heath Canada released proposed amendments to the Food and Drug Regulations and the Medical Devices Regulations, providing for the public release of clinical information contained in drug submissions and medical device applications (for further details please see "Proposed amendments to Food and Drug Regulations and Medical Devices Regulations"). On April 10 2018 Health Canada published a draft guidance document addressing the implementation of the proposed amended regulations.
According to the guidance, implementation will occur in four phases over four years. In the first phase, Health Canada plans to proactively publish clinical information contained in all:
By the fourth year, this will expand to include clinical information contained in all:
Upon issuance of a negative regulatory decision, the publication process will be delayed by 30 days for the manufacturer to seek reconsideration or an appeal. Publication will be initiated upon completion of any reconsideration or appeal.
Manufacturers will be notified by email of the list of documents that will be publicly released and will have 20 days to propose redactions and de-identify the data. Data anonymisation must be explained in a separate anonymisation report. Redactions may be proposed for certain categories of clinical information that remain confidential business information.
Clinical information from past submissions will be available upon request through Health Canada's clinical information portal.
Health Canada is seeking stakeholder comments on the draft guidance until June 25 2018.
For further information on this topic please contact Brandon Heard at Smart & Biggar/Fetherstonhaugh by telephone (+1 416 593 5514) or email (email@example.com). The Smart & Biggar/Fetherstonhaugh website can be accessed at www.smart-biggar.ca.
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