Answer: No. Full implementation of this guidance document will commence twelve months after registration of the Regulations Amending the Food and Drug Regulations (Labelling, Packaging and Brand Names of Drugs for Human Use) in Canada Gazette Part II. New requirements will be applied to submissions received on or after June 13, 2015. They will not be applied retroactively and they will not be applied to submissions in the queue.
Answer: A separate brand name assessment framework/guidance is currently being developed for non-prescription (OTC) products and natural health products. Brand name review for disinfectants is provided within the Guidance document - Disinfectant drugs (January 2014).
Answer: As is customary, the Therapeutic Products Directorate (TPD) and Biologics and Genetic Therapies Directorate (BGTD) will work with sponsors to resolve any issues prior to the issuance of a Notice of Non-compliance according to Health Canada's Guidance for Industry: Management of Drug Submissions.
A brand (proprietary) name is not essential to obtain an NOC/DIN for a drug submission. An NOC/DIN can be issued under the drug's common/proper name. However, in this case, a sponsor may not sell the product under a name other than the common/proper name in final dosage form without filing a supplemental submission and obtaining an NOC or DIN for a different brand name.
If a sponsor does not wish to move forward with the use of the proper/common name and all brand names are deemed unacceptable, a Notice of Non-Compliance will be issued.
For submissions of less than 180 days, since only one name will be reviewed, the sponsor's response to a NON may include information to address the concerns but proposals for a different new brand name should be filed in a new submission.
Sponsors may request for a formal reconsideration of the decision if it results in a Notice of Non-compliance-Withdrawal Letter (NON/W) according to Health Canada's Guidance for Industry: Reconsideration of Final Decisions Issued for Human Drug Submissions.
Answer: Health Canada will review a sponsor's brand name assessment as part of the drug submission within the performance standard outlined in Appendix 3 of the Guidance for Industry: Management of Drug Submissions depending on the applicable submission type. Health Canada cannot hold a name until such time as the drug submission as a whole is reviewed for safety and efficacy.
Answer: Health Canada will review a sponsor's brand name assessment as part of the drug submission within the performance standard outlined in Appendix 3 of the Guidance for Industry: Management of Drug Submissions depending on the applicable submission type. Associated fees are provided in the Guidance Document: Fees for the Review of Drug Submissions and Applications.
For submission types that involve a review target of 180 days or longer, Health Canada will complete an initial review of the proposed brand name within the first 90 days of the submission. The sponsor will be notified at that time if any issues exist with the proposed brand name. A second but abbreviated review will be conducted 30 days prior to issuance of NOC/DIN to confirm no other names have been approved recently with a potentially confusing name.
If the initial brand name is found to be unacceptable, a new brand name and assessment must be submitted within the time requested by Health Canada. If not submitted, the submission will be given an NOC/DIN for the proper/common name. A subsequent new submission (to propose a new brand name) will be subject to all associated costs and timelines.
For submissions of less than 180 days that require a brand name assessment (e.g., labelling only), only one name will be reviewed within the timelines and associated fees.
Answer: An NOC or DIN will be issued for use of the proper/common name; if the sponsor does not agree to the use of the proper/common name, a NON will be issued. Sponsors will have 90 days to respond to the NON as per Health Canada's Guidance for Industry: Management of Drug Submissions.
Sponsors may request for a formal reconsideration of the decision if it results in a Notice of Non-compliance-Withdrawal Letter (NON/W) according to Health Canada’s Guidance for Industry: Reconsideration of Final Decisions Issued for Human Drug Submissions.
Answer: If a brand name assessment is not provided, the sponsor will be notified at the time of screening. Failure to provide a brand name assessment will result in the brand name being deemed unacceptable and Health Canada will move forward with the use of the proper/common name.
In the case of a Labelling Only submission, the brand name assessment will be requested through a Screening Deficiency Notice.
Answer: For submissions of 180 days or greater that require a brand name assessment, a maximum of 2 brand names can be submitted at time of filing. Sponsors must identify which brand name has priority for review. Health Canada will review one brand name at a time. The alternate name will not be reviewed or considered for confusion with other proposed or marketed products authorised for use in Canada until agreement has been reached between Health Canada and the sponsor that the first brand name is no longer under review or further consideration.
Specifically, the sponsor has the following options if the first brand name is deemed unacceptable:
For submissions of less than 180 days that require a brand name assessment (e.g., labelling only), only one name will be reviewed within the timelines and associated fees.
Answer: No. A maximum of 2 brand names may be submitted for submissions of 180 days or longer. A third name and its accompanying brand name assessment must be filed as a Labelling Only Submission.
Answer: A maximum of 2 brand names may be submitted at time of filing for submissions of 180 days or longer. Health Canada discourages the practice of changing a brand name mid-review. If due to unforeseen circumstances, a sponsor needs to change a proposed brand name during the Health Canada review period. An agreement is also required between Health Canada and the sponsor that the first brand name is no longer under review or further consideration. A new brand name and assessment must be submitted within the time requested by Health Canada.
For submissions of less than 180 days, the sponsor cannot change a name during the review process.
Answer: An initial brand name assessment will be completed within 90 days of being accepted into review. Any problems with a proposed name are communicated promptly to the sponsor as they are identified. The final assessment is completed in the 30 days prior to review target date.
Answer: No. Health Canada is unable to reserve a sponsor's brand name if found acceptable until such time as a decision is made regarding the full drug submission.
Answer: Not all brand name changes require a brand name assessment. A submission will be processed as administrative where the proper/common name is written in full or the brand name is previously approved, and the following changes are proposed:
Answer: A brand name change that requires a brand name assessment must be submitted as a Labelling only Submission and includes the following:
Please note the requirements below with respect to a manufacturer's name or abbreviation of a manufacturer's name.
Answer: The first submission in which a new manufacturer name or abbreviation of the name is proposed in combination with a proper or common name will be subject to an initial brand name review as per the criteria established in Section 2.2 and should be submitted as a Labelling Only submission. A LASA assessment is not required. If the name is deemed acceptable, all subsequent submissions using the same manufacturer name or abbreviation of the name in combination with a proper or common name written in full will be processed as administrative and will not require a brand name assessment. Sponsors are encouraged to file a submission for a new proposed manufacturer name or abbreviation of the name in advance of other submissions with the same prefix so that the processing of the latter will not be delayed by the brand name review process.
Submissions in which the approved manufacturer's name or abbreviation of the manufacturer's name is combined with a proper/common name that has been altered or truncated will require a LASA assessment.
Answer: The addition of a modifier/abbreviation to a brand name that is already marketed requires sponsors to submit an assessment using Appendix 2 of the guidance (e.g., considerations on modifiers and abbreviations). Simulation exercises will not be required. The modifier portion of the proposed brand name will be subject to the Initial Brand Name Review Criteria.
Answer: Generic versions should contain the same modifier as the brand name version or innovator product to distinguish different dosing considerations or indications (where permissible with respect to copyright/trademark law). Modifiers should not be added to generic versions if none are associated with the innovator product. In the circumstances that a modifier is proposed to emphasize an attribute of the generic product in order to reduce the risk of medication errors, a rationale should be submitted to Health Canada to explain the selection of the modifier.
Answer: With priority reviews, early ongoing discussions will take place and as is customary, the Therapeutic Products Directorate (TPD) and Biologics and Genetic Therapies Directorate (BGTD) will work with sponsors to resolve any issues.
Answer: Some proposed brand names have undergone a global development and testing process with the goal of identifying a global brand name. This testing may or may not have involved Canadian respondents and given consideration to the use of the product in Canada.
If a brand name assessment has been completed in another jurisdiction, there may be a need for additional assessment to reflect the Canadian context. The first step in determining the relevance of information to the Canadian context is to confirm through a Drug Product Database (DPD) and Licensed Natural Health Product Database (LNHPD) search that the Look-alike Sound-alike (LASA) name candidates (i.e. the existing brand names that could be confused with the proposed brand name) are identical to those authorised for use in Canada. These LASA name candidates will have been generated via database searches, simulations and Failure Mode and Effects Analysis (FMEA) type processes. A difference in indication or other non-name attributes may render the name more or less likely to be confused in Canada and should be factored into the assessment.
It is also necessary to give consideration to the process maps (as identified in Section 2.3.2 Simulate) developed for the product. If the product will be used in much to the same way, the outcome of the simulations will be of relevance to making a decision about the acceptability of a name in Canada.
If the process map is similar, the name candidates are identical and a risk assessment process was completed, final consideration should be given to any issues that may arise due to the bilingual nature of the Canadian healthcare environment.
If required, Health Canada may request additional information to assess the safety of the proposed name for the Canadian market.
Answer: Health Canada is interested in reviews that have been completed by regulatory counterparts. As an independent regulatory authority, Health Canada will make its own decisions regarding the acceptability of a proposed brand name as the circumstances for approval are not always identical across all jurisdictions, e.g., different names of comparison, different indications for use etc.
Answer: Statistics indicate that Francophones represent approximately 21% of the Canadian population. It is therefore recommended that French speaking Canadians account for 20-25% of participants represented in the simulation exercises for the testing of proposed brand names.
Answer: The performance of a drug name in another jurisdiction is of interest in the Canadian context. For the information to be valid in informing a decision by Health Canada, it is important to establish that the names that could be confused with the proposed brand name in Canada are identical to the names that could be confused with the brand name in another country. Non-name attributes such as strength, formulation and indication would also need to be consistent across the two jurisdictions.
Answer: The sponsor is not required to provide additional evidence to justify a negative response in the initial brand name review (Section 2.2); however a rationale can be provided and may be helpful. Health Canada will review the proposed brand name using the same criteria and in the situation where there is a difference in response, Health Canada may request additional information before making a decision to reject a brand name.
In the circumstances that a proposed brand name fails the initial review, Health Canada will contact the sponsor to request an alternate brand name, accompanied by a brand name assessment, if applicable (in accordance with Section 1.4 Scope and Application). Information will be provided regarding the basis for the negative decision.
Answer: In general, Health Canada does not think that the use of INN or USAN stems in brand names is a desirable naming practice. As part of the initial brand name review, Health Canada will review whether the proposed name contains a USAN (U.S. Adopted Name) or INN (International Non-proprietary Name) stem for the same or different pharmacological/chemical trait. If the use of an INN/USAN stem is in the same location as specified by INN or USAN, it would result in the name failing the initial review. In these circumstances, Health Canada will not review the sponsor's brand name assessment and will contact the sponsor to request an alternate brand name, accompanied by a brand name assessment. However, if the same letter sequence is used elsewhere in the brand name, Health Canada will continue the review of the proposed brand name including the sponsor's brand name assessment taking into consideration the use of the INN/USAN stem and the potential for confusion.
Answer: The guidance does not require explicit testing of a proposed brand name for promotional aspects. However, Health Canada will review each proposed brand name using the initial brand name review criteria (Section 2.2. Initial Brand Name Review). This review will be done for all brand names regardless of whether a LASA brand name assessment is required. The criteria address naming practices that Health Canada view as misleading (per Section 9 of the Food and Drugs Act; C.08.006 of the Food and Drug Regulations). Sponsors should assess all brand names using these criteria prior to initiating a LASA Brand Name Assessment. Sponsors may also consult the Guidance Document: Labelling of Pharmaceutical Drugs for Human Use Section 4 entitled "Text and Text Content".
Answer: A brand name assessment will remain valid when it can be confirmed by the sponsor that none of the following factors have changed or modified from the time that the brand name assessment was completed:
Answer: Raw data will be limited to database search results. However, as a regulator, Health Canada reserves the right to request additional information or material (including raw data for other aspects of the brand name review when necessary), or define conditions not specifically described in this document, in order to allow the Department to adequately assess the safety, efficacy or quality of a drug (C.08.002 and C.01.014 of the Food and Drug Regulations). Health Canada is committed to ensuring that such requests are justifiable.
Answer: A brand name assessment is required for Schedule C products however, given the nature of how radiopharmaceuticals are managed and utilized, simulation exercises will not be required.
Answer: Although radiopharmaceuticals and other Schedule C drugs are not currently assigned DINs, Health Canada will make their brand names searchable in the online Drug Products Database. As a result, sponsors conducting brand name searches using the DPD in accordance with the Review of Drug Brand Names Guidance will be able to conduct brand name assessments against radiopharmaceuticals and other Schedule C drugs.
Answer: A brand name assessment is required for EUNDs in which a brand name is proposed however, given the nature of how these products are managed and utilized, simulation exercises will not be required.
Answer: The guidance does not specify any threshold of acceptability or unacceptability. A score of less than 50% does not imply acceptability, and a score of greater than 50% does not imply unacceptability. The 50% is a reporting threshold. It is the combination of all the evidence gathered throughout the name assessment process that is considered in making a decision about the acceptability/unacceptability of the brand name.
Answer: Health Canada recognizes that the orthographic and phonetic similarity measures may not capture all dimensions of similarity (e.g., similarity in handwriting). Drug use process simulations should incorporate handwritten prescriptions if the process map suggests that real world prescriptions for the product may be handwritten. Therefore, any issues involving handwriting have a chance to come to light in these simulations.
Answer: It is recognized that all-inclusive medication-use process mapping may not be possible or relevant. As per Section 2.3.2 Simulate and Appendix 3 - Medication-Use Process Maps of the guidance, the most likely and anticipated pathways and communication points should be mapped. These will depend on the indications and intended application of the drug. Key participants in the product's use, from initiation of ordering or selection to use by the end user, and the major communication flow amongst the users, should be mapped. Secondary communication points may also be indicated if relevant.
Answer: The medication-use simulation tests do not require the parallel use of control, already marketed drug names. For all drugs, realistic circumstances of use need to be simulated. For prescription products these will include complete prescriptions using drug strength and dosing. Examples of factors that will drive the scope of simulation tests include: the product's proposed indications, the target population, the dosing, and whether manipulation is required before administration.
Answer: Due to the specialized nature of certain products and its intended users, it may not be possible to bring together 100 Canadian healthcare professionals. In this circumstance, a rationale should be submitted to Health Canada as to why a particular number was chosen.
Answer: The Medication-Use Process map(s)should be used as the basis for determining the number of participants and composition of an FMEA panel. In addition to panel members that may be drawn from the brand name assessment company, the FMEA panel must include actively practising healthcare professionals who have experience in the field of use of the proposed product.
Answer: Yes. Practising healthcare professionals that have participated in the simulation studies can also participate in an FMEA panel. Sponsors must however still meet the requirement for the participation of 100 practising healthcare professionals in the simulation studies.
Answer: The final FMEA report is expected to be an accurate presentation of the deliberations of the panel, with the full scope of opinions being reported. The FMEA team must include active practitioners in the field of use for the product whom handle/prescribe the drug (orders) in the various specialty areas in distinct practice settings and circumstances. These 'experts' seek to identify all potential things that can go wrong with a process or product (i.e., its failure modes).
The FMEA team will review and assess the search and simulation findings, and also consider any additional issues they, as practitioners or potential users of the product, may identify. It is expected that any agreement among panel members will be driven by the evidence before them, including discussions regarding the questions noted in Section 18.104.22.168 of the guidance. The FMEA panel's summary report should outline both "safe" and "vulnerable" aspects of the drug name and non-name attributes, as identified during the team's analysis.
Answer: Sponsors should report safety events resulting from product name confusion to the Canada Vigilance Program. Healthcare professionals and consumers can report safety events resulting from product name confusion to the Canada Vigilance Program or the Institute for Safe Medication Practices Canada.
Answer: Safety issues may arise once a product is marketed and used by healthcare professionals, patients and consumers on a day-to-day basis in an uncontrolled environment (as opposed to a controlled clinical trial environment).
Health Canada receives medication incident reports from a variety of sources including sponsors, healthcare professionals, patients/consumers, the Institute for Safe Medication Practices Canada, the Canadian Institute for Health Information, foreign regulators and literature. As medication incidents are preventable in nature, near miss reports and hazardous circumstances are just as important as those incidents that have led to harm. Near miss reports and hazardous circumstances provide a signal/warning that there is potential for serious harm if action is not taken in a timely manner.
If a potential health risk is identified, Health Canada will address the issue and work in collaboration with the sponsor to develop mitigation strategies. Health Canada takes a name change very seriously. This step will be taken when no other sustainable risk mitigation strategies are feasible.
Also, post-market experience with a brand name in another jurisdiction may contribute to pre-market decisions regarding the acceptability of a proposed brand name.
Answer: No, this is optional. The theoretical foundations for screen-based simulations are based on experimental psychology and psycholinguistic research.Footnote 2,Footnote 3 These experiments are easy to control and efficient (i.e., capable of testing many names and many people). These tests can provide a simplified simulation of reality that focuses on confusability in the three cognitive domains most often implicated in name confusion errors: vision, hearing and short-term memory.
The types of participants should reflect the population of users (e.g., physicians, nurses, pharmacists, patients) identified in the process map for the proposed drug. During pilot testing at least 25 people from each category of principal participants participated in the screen-based simulations.
The purpose of the visual perception test is to determine the extent to which the written form of the proposed brand name is accurately recognized, and to identify what other names may be incorrectly substituted for the proposed name when it is misperceived. This experiment simulates the real world task where clinicians read a typewritten drug name and must identify it. A name is very briefly displayed to the participant on the computer screen, in a font style and size comparable to what would be seen on typical order entry screens. The task is to identify the name as quickly and as accurately as possible by (a) typing the name into a free-text response box and (b) by selecting it from a pick list of alternatives, where the alternatives consist of the proposed name and its 5 nearest orthographic neighbours. Because errors in visual perception are rare under perfect conditions, visual distortion or 'noise' may be added or the duration of exposure may be shortened to make the task more challenging. Errors occur when the name that is identified is not the name that was originally presented. The task produces an error (or accuracy) rate for each name, as well as a frequency-sorted list of the names that may be substituted for the target name when it is misperceived.
The purpose of the auditory perception test is to determine the extent to which the spoken form of the proposed name is accurately recognised and to identify what other names may be incorrectly substituted for the proposed name when it is misperceived. This experiment simulates the real world task where clinicians hear a health product name spoken in person or over the phone (or on voice mail) and must identify the spoken name. A name is played for the participant over headphones. The task is to identify the name as quickly and as accurately as possible by (a) typing the name into a free-text response box and (b) by selecting it from a pick list of alternatives, where the alternatives consist of the target name and its 5 nearest phonetic neighbours. Because errors in auditory perception are rare under perfectly quiet conditions, multi-speaker noise is added to the task to make it more difficult and realistic. Errors occur when the name that is identified is not the name that was originally spoken. The task produces an error (or accuracy) rate for each name, as well as a frequency-sorted list of the names that may be substituted for the target name when it is misperceived.
The purpose of the memory test is to document the extent to which a proposed name is prone to short-term memory errors and to identify what other names may be incorrectly substituted for the proposed name when it is recalled incorrectly. The memory task simulates the real world situation wherein a person reads a prescription in one setting (e.g., on a computer screen or written prescription or chart) and then needs to go to another setting (e.g., to a computer or to shelf stock) and select or retrieve the product. Errors occur when the product that is retrieved or selected is not the one that was on the original order. In the experiment, a typewritten drug name is briefly presented to the participant on a computer screen. The participant completes a brief mental arithmetic task meant to simulate real-world distraction. The participant then identifies the target name, first by typing it into a free-text response box and then by selecting it from a pick list of alternatives, where the alternatives consist of the target name and its 5 nearest phonetic neighbours. The task produces an error (or accuracy) rate for each name, as well as a frequency-sorted list of the names that may be substituted for the target name when it is misremembered.
Experimental software to run psycholinguistic tests (e.g., SuperLab, E-Prime) is commercially available.
As stimulus materials, each task should include the proposed brand name (i.e., the 'test name') along with 50 additional 'filler names'. The filler names are included so that the same participants can complete all three tests (visual perception, auditory perception, and short-term memory) without knowing which name is the focus of the study and without easily being able to learn or memorize the names as they proceed from one task to the next. To further safeguard against practice effects, the order of the tasks should be changed for each subject and the order of presentation of names within each task should be randomized for each subject.
Answer: Health Canada pilot tested this technique. Both prescription and non-prescription products were included in these pilot tests. Several previously published papers by Dr. Lambert may be useful as background.
For further questions contact: firstname.lastname@example.org
It is the responsibility of the sponsor to complete a search of the DPD and LNHPD to determine all names that have been approved from the time that the brand name assessment was completed.
Garnham A. Psycholinguistics: Central topics. New York: Methuen; 1987
Gernsbacher MA, ed. Handbook of psycholinguistics. San Diego, CA: Academic Press; 1994.