Health Canada released the Draft Revised Guidance Document for
Industry ̶ Review of Drug Names for Look-alike Sound-alike
Attributes (the Guidance) in early 2013.1 The Guidance
seeks to clarify the process to be followed and information to be
submitted to Health Canada for drug name approval, with the
ultimate goal of reducing medication errors resulting from name
confusion. While it was expected that the Guidance would be
finalized by early 2014, we understand that a new version of the
Guidance is expected for release in mid-2014.
Under the current draft of the Guidance, drug sponsors need to
give Health Canada significantly more detailed information about
the potential for a proposed drug name to be confused with another
product authorized for use in Canada.
The current draft of the Guidance builds on Health Canada's
guidance document currently in place2 , and seeks to
address the inconsistencies in the quality and type of evidence
submitted by sponsors. While the guidance currently in place offers
suggestions as to what a sponsor's submission can include
without clear direction, Health Canada is now seeking objective
information in a standardized format. Under the 2013 Guidance, a
sponsor must implement a three-step "search, simulate and
synthesize" approach to its assessment of the potential for
brand name confusion. The three steps are described below.
Search. The sponsor is expected to conduct an
extensive search for similar drug names, using search engines and
databases, and identify the most similar names based on specific
algorithmic similarity scores.3 The sponsor is also
expected to search published literature and provide any reports of
foreign regulators regarding the name.
Simulate. The sponsor is expected to conduct
experiments to test the confusability of the brand name in
auditory/visual perception and memory tasks (psycholinguistic
testing) and to simulate each stage of the medication-use process
to assess confusability.
Synthesize. The sponsor is expected to combine
results from the Search and Simulate phases, put the brand name
through a failure mode and effects analysis (FMEA) to further
identify any problems, and submit its final rationale for approval
of the name.
Health Canada will conduct an initial brand name review in which
the name will be subjected to specific threshold questions. If the
proposed drug name survives the initial brand name review, Health
Canada will review the sponsor's assessment in detail, conduct
its own reviews, and request further information if necessary to
assess whether the proposed name is likely to cause confusion with
other health products, or is misleading with respect to therapeutic
effectiveness, composition or safety.
If the drug name is accepted, Health Canada can issue a drug
identification number (DIN) and/or a Notice of Compliance (NOC). If
the drug name is rejected, Health Canada can refuse to issue a DIN
or NOC, and the sponsor is left with the options of submitting an
alternative name, proceeding with the proper name or common name
alone, or appealing the decision through a Request for
Reconsideration to Health Canada.
The goal of the Guidance is to make the drug name review process
as a whole more transparent. The result, however, is a substantial
and onerous set of requirements that increases the sponsor's
burden significantly. Sponsors should expect an increase in the
cost and time required to prepare assessments, and should also
expect increased rejections of proposed brand names.
The Guidance has prompted stakeholder concerns about the onerous
obligations of the sponsor assessment process and inconsistencies
with requirements in foreign jurisdictions. While the next version
of the Guidance is expected to address some of these stakeholder
concerns, we anticipate that the finalized Guidance will ultimately
represent a more stringent approval process in Canada.
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