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- 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.
www.canada.ca › en › health-canadaFrequently Asked Questions - Guidance Document for Industry ...
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What is a non-proprietary name?
What is a proprietary name of a drug?
Are biosimilar drugs naming in Canada?
Can a drug have more than one non-proprietary name?
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.
All biologic drugs, including biosimilars, reference biologics and innovator biologics, would receive a unique, meaningless 4-letter suffix appended to the non-proprietary name. Products sharing the same non-proprietary name would be distinguished by the suffix.
Dec 15, 2023 · How are INNs chosen? A group of experts at the WHO called the INN Expert Committee carefully selects INNs based on several criteria: Uniqueness: The name should be unique and not resemble existing drug names or trademarks to avoid confusion.
How are drugs researched and approved for sale in Canada? A brand name drug manufacturer spends many years researching and developing a new drug before it can be approved for sale in Canada. The drug manufacturer applies for a patent on the drug so that no other company can manufacture or sell it.
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Mar 25, 2024 · The non-proprietary name of a drug is the name accepted by a competent scientific body or authority, such as the USAN or BAN. The non-proprietary names of newer drugs are kept uniform by an agreement to use the Recommended International Nonproprietary Name (rINN) in all member countries of the World Health Organization (WHO).
If the medicinal ingredient name is not found in the list, enter the new medicinal ingredient name in this field using the International Non Proprietary (INN) terminology, as it is the Health Canada’s standard to assign the preferred name to ingredients.
Unbiased mentions of a drug place the nonproprietary name first and follow it with the trade name in parentheses, if relevant (for example, "doxorubicin (Adriamycin)"). This pattern is important for the scientific literature, where conflict of interest is disclosed or avoided.
