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2014, Health Canada released a revised guidance on the review of drug brand names, proposing significant changes to the draft guidance released in February, 2013.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 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.
The policy objective of the guidance is to provide manufacturers with direction on the process to be followed, and the information to be submitted to Health Canada, regarding the potential for a proposed name to be misleading or confused with another product authorized for use in Canada with the aim of prevention medication errors.
The guidance applies to both innovator and generic drugs for human use for which a brand name is proposed. It applies to pharmaceutical prescription drugs, biologics and radiopharmaceuticals, drugs that are sold to the general public with the intervention of a healthcare professional, usually a pharmacist (e.g. insulin, nitroglycerin), and drugs that are sold directly to healthcare professionals and are intended for professional use (e.g. anaesthetics).
Key changes made to the guidance following consultation with industry include the following:
- 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 memory tasks.
- A sponsor will not be required to use the specific 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 per cent combined orthographic and phonetic score. Any name with a combined score of 50 per cent 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 per cent 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 per cent 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 identified.
- 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 and 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 toward finalization but no date has been set for publication in the Canada Gazette Part II.