Interpretation of the Incorporated by Reference (IbR) List for pediatric-focused drug classes
Purpose
This page gives manufacturers additional information for filings of new drug submissions, or their supplements, for human drugs with pediatric indications seeking deeming under the Order Providing for Reliance on Decisions of, or Documents Produced by, Foreign Regulatory Authorities in Respect of Certain Drugs (the Order).
- The Ministerial Reliance Order: About the Order
- List of classes of drugs and foreign regulatory authorities for the purposes of reliance on decisions or documents (IbR List): Human drugs
Use of the Anatomical Therapeutic Chemical (ATC) classification system
Health Canada is using the World Health Organization’s (WHO) ATC classification system to define the drug classes that are within scope of the Order, where possible. In the ATC classification system, medicinal ingredients are divided into groups based on the organ or system on which they act, and their therapeutic, pharmacological and chemical properties. Health Canada chose this system for the IbR List because it is:
- an internationally recognised system for drug classification
- accessible to all users of the IbR List
- already used by Health Canada in our Drug Product Database
Learn more about the ATC classification system:
Interpretation of the classes of drugs on the IbR List
The ATC classification system is used to define the pediatric-focused drug classes for which New Drug Submissions (NDS) and Supplements to NDS (SNDS) could be filed seeking deeming under the Order as follows:
NDS
The pediatric focused drug classes listed in Part 1: General Deeming, Division 1: New Drug Submissions uses the ATC classification system to define what falls within a class.
- This means that only NDS for drugs that fall within a ATC classification on the IbR List may be eligible for deeming under the Order
- The drug subject to the submission must also be in alignment with any qualifiers included in the corresponding qualifier column of the IbR List, and the foreign drug authorisation must originate from one of the Foreign Regulatory Authorities (FRAs) listed in the corresponding FRAs column
SNDS
The pediatric-focused drug classes listed in Part 1: General Deeming, Division 3: Supplements to NDSs are defined using the overall class at the anatomical main group level of the ATC classification system. The ATC classification system has also been used to define qualifiers to a drug class where it makes sense to do so. Descriptive language has been used when there is no suitable ATC classification available that appropriately represents the qualifier required to refine the class.
- Only SNDS for drugs that fall within classes of drugs included under the ATC classification listed on the IbR List and any related ATC or descriptive qualifiers may seek deeming under the Order
- The foreign drug authorisation must originate from one of the FRAs listed in the corresponding FRAs column
How qualifiers operate under the IbR List
The qualifier(s) are added to refine the scope of the broader class set out in the first column of the IbR List. The drug subject to the submission or supplement in Canada must fall within the drug class as narrowed by any applicable qualifiers.
If the class includes qualifiers that affect the corresponding FRAs, the qualifiers have been assigned numbers. A corresponding number has also been assigned in the FRAs column to note which FRAs are applicable to that specific qualifier within the class.
For example, the class “A16AX - Various alimentary tract and metabolism products under the ATC classification” is on the IbR List under Part 1: General Deeming, Division 1: New Drug Submissions. It is a class with a number of different types of numbered qualifiers.
| Drug class | Qualifier | Foreign Regulatory Authorities | Effective date |
|---|---|---|---|
A16AX - Various alimentary tract and metabolism products under the ATC classification |
|
|
July 15, 2026 |
When interpreting this class on the list, this is how it should be read:
- A manufacturer could request deeming under the Order for a submission filed with Health Canada seeking a pediatric indication (qualifier 1) for a drug included under this ATC class. If the submission is not for a cell therapy, gene therapy, RNAi-based therapy, or a tissue engineered product, nor for a biosimilar then it can seek deeming based on decisions for foreign drugs from the European Medicines Agency (EMA), Swissmedic of Switzerland, the United Kingdom’s Medicines and Healthcare products Regulatory Agency or the United States Food and Drug Administration (U.S. FDA).
- A manufacturer could request deeming under the Order for a submission filed with Health Canada seeking a pediatric indication (qualifier 1) for a drug included under this ATC class. If the submission is for a cell therapy, gene therapy, RNAi-based therapy, or a tissue engineered product (qualifier 1.1), the manufacturer could only seek deeming based on decisions for foreign drugs from the U.S. FDA or the EMA.
- A manufacturer could not request deeming under the Order for a submission filed with Health Canada seeking a pediatric indication (qualifier 1) for a drug included under this ATC class, if this submission is for a biosimilar (qualifier 1.2).
Biosimilar drugs
NDS or SNDS for biosimilar drugs cannot currently seek general deeming under the Order. This applies to drugs seeking a notice of compliance on the basis of a direct or indirect comparison to another drug listed in Schedule D to the Food and Drugs Act that is authorized to be sold in Canada.
As provided in the example above, where a class for human drugs includes biologic drugs, the qualifiers and FRAs column read together indicate that biosimilar submissions cannot seek general deeming at this time.
Health Canada will notify sponsors before such submissions or supplements can be filed seeking deeming under this part of the Order.