On March 6, 2014, Health Canada
released a revised Guidance on the review of drug brand names,
proposing significant changes to the draft Guidance released in
February, 2013. The revised Guidance is still in draft form
although it is expected to be finalized and posted on Health
Canada's website in or around June, 2014. There will be a one
year transition period to permit compliance and full
implementation. The transition period will begin when the final
Guidance is posted by Health Canada.
Key changes made following consultation with industry include
Non-prescription drugs are no
longer subject to the new regime. However, the Guidance states that
a separate brand name assessment framework will be developed for
consumer health products. Health Canada says work is ongoing with
the consumer health product industry on the contents of an
acceptable framework but no timeline for the disclosure of such a
framework has been provided.
The requirement for
psycholinguistic testing has been removed. A sponsor will no longer
be required to engage in screen-based tests of a proposed brand
name in auditory perception, visual perception and short-term
A sponsor will not be required to
use the POCA algorithm in its brand name searches. It can use
another search engine but must still search the proposed brand name
against the Drug Product Database and the Licensed Natural Health
Products Database. Health Canada itself will continue to use the
The threshold for similarity
score has been changed to a 50% combined
orthographic and phonetic score. Any name with a combined score of
50% or higher similarity must be included in the search results
submitted to Health Canada. Formerly, sponsors were required to
identify to Health Canada any name with a similarity score of 65%
or above in either phonetic, orthographic or combined
phonetic/orthographic similarity. Additionally, there is no
longer a requirement to provide Health Canada with the five
phonetic and five orthographic "nearest neighbours" in
addition to the list of names with a 50% combined score.
The requirement for patients to
be involved in all required testing has been removed. The
Medication-Use Process Map has been amended to delete the
comprehensive "patient" section. Further, the Failure
Modes and Effects Analysis (FMEA) no longer requires patient
involvement. However, the Guidance does state that where
applicable, patients should be identified in
the Medication-Use Process Map.
There is no longer a requirement
that all raw data generated in the Search, Simulate and Synthesize
steps be submitted to Health Canada. However, the results of the
searches of the Drug Products Database and the Licensed Natural
Health Products Database must still be provided to Health Canada.
The date of completion of these searches must be clearly
Two brand names may be submitted
by a sponsor (up from one name in the original draft). However,
sponsors must identify which brand name has priority for review as
Health Canada will only review one brand name at a time.
Health Canada will post a Question & Answer document on its
website at the time it posts the final Guidance.
Health Canada has advised that the "plain language
label" regulations that were introduced in June, 2013 are
still pending. Comments have been gathered and the regulations are
moving towards finalization but no date has been set for
publication in the Canada Gazette Part II.
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guide to the subject matter. Specialist advice should be sought
about your specific circumstances.
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