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the draft Guidance released in February 2013.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.
The requirement for psycholinguistic testing has been
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 POCA algorithm.
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.
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.
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.
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