List of classes of drugs and foreign regulatory authorities for the purposes of reliance on decisions or documents (IbR List): Human drugs

Find the eligible classes of human drugs and their corresponding foreign regulatory authorities (FRAs) in the incorporated by reference (IbR) list under the Ministerial Reliance Order (the Order).

About the IbR List

The “Order Providing for Reliance on Decisions of, or Documents Produced by, Foreign Regulatory Authorities in Respect of Certain Drugs” (the Order) came into force on July 15, 2026. Under the Order, certain information in a drug submission can be deemed to meet certain requirements of the Food and Drug Regulations based on a decision or document produced by an FRA.

The “List of classes of drugs and foreign regulatory authorities for the purposes of reliance on decisions or documents” (IbR List) is incorporated by reference into the Order. It indicates the classes of drugs and their corresponding FRAs that are eligible for deeming.

The IbR List is published as 2 distinct lists, this list for human drugs and another list for veterinary drugs.

If you’re looking for information on veterinary drugs eligible under the Order, visit the List of classes of drugs and foreign regulatory authorities for the purposes of reliance on decisions or documents (IbR List): Veterinary drugs.

The IbR List has parts, divisions and subdivisions based on the type of submission and the deeming scenario:

Part 1: New drug submissions (NDS)
- Division 1: General deeming
- Division 2: 120-day filing
- Division 3: Joint review
Part 2: Abbreviated new drug submissions (ANDS)
- General deeming
Part 3: Supplements to drug submissions
- Division 1, subdivision 1: General deeming, supplements to new drug submissions (SNDS)
- Division 1, subdivision 2: General deeming, supplements to abbreviated new drug submissions (SANDS)
- Division 2: 120-day filing (SNDS)
- Division 3: Joint review (SNDS)

Individual listings include:

the class of drugs that is eligible for deeming
qualifiers to help define the class of drugs (in some cases)
- For example, qualifiers can restrict the class of drugs to certain target populations, indications or dosage forms
the FRA on which a manufacturer can rely for that class of drugs
the effective date which indicates when the listing was last amended

The same drug classes may appear in multiple parts and divisions of the IbR List.

Health Canada maintains and updates this List as required. Before making a change to the IbR List, an assessment will be done to determine whether the update is necessary for a health or safety purpose, or is otherwise in the public interest. That assessment will also seek to determine whether it is unlikely to result in unacceptable risks or uncertainties to health, safety or, if applicable, the environment, based on the Order’s benefits and conditions.

Learn more:

The IbR List

Interpretation

EMA means the European Medicines Agency and the European Commission for the European Union
HSA means the Health Sciences Authority for Singapore
Swissmedic means the Swiss Agency for Therapeutic Products for Switzerland
TGA means the Therapeutic Goods Administration for Australia
U.K. MHRA means the United Kingdom Medicines and Healthcare products Regulatory Agency for the United Kingdom
U.S. FDA means the United States Food and Drug Administration for the United States

Part 1: New drug submissions (NDS) for human drugs

Division 1
General deeming

Drug class	Qualifiers	Foreign regulatory authorities	Effective date
A05AA – bile acids and derivatives under the ATC classification	When the indications include an indication for pediatric populations	EMA, Swissmedic, U.K. MHRA, U.S. FDA	July 15, 2026
A16AX – various alimentary tract and metabolism products under the ATC classification	1. Subject to applicable exceptions in (1.1) and (1.2), when the indications include an indication for pediatric populations 1.1 When the drug referred to in article 1 is a cell therapy, gene therapy, RNAi-based therapy or tissue engineered product 1.2 When the drug referred to in article 1 is listed in Schedule D to the Food and Drugs Act and is subject to a submission seeking a notice of compliance on the basis of a direct or indirect comparison between the drug subject to the submission and another drug that is authorized to be sold in Canada	1. EMA, Swissmedic, U.K. MHRA, U.S. FDA 1.1 EMA, U.S. FDA 1.2 no applicable foreign regulatory authority	July 15, 2026
B05BA02 – fat emulsions under the ATC classification	When the emulsion consists of fish oil triglycerides that meets all the following: administered via intravenous route indicated for treating parenteral nutrition-associated cholestasis in pediatric patients.	EMA, Swissmedic, U.K. MHRA, U.S. FDA	July 15, 2026
J04A – drugs for treatment of tuberculosis under the ATC classification	When the indications include an indication for pediatric populations and is in any of the following drug formats: oral preparations: powders and granules orodispersible preparations chewable preparations liquid preparations oromucosal preparations solid preparations, including mini-tablets capsules preparations for inhalation nasal preparations rectal preparations cutaneous preparations transdermal preparations preparations for parenteral administration	EMA, Swissmedic, TGA, U.K. MHRA, U.S. FDA	July 15, 2026
L01XX05 – hydroxycarbamide (hydroxyurea) under the ATC classification	When the indications include an indication for pediatric populations and is in any of the following drug formats: oral preparations: powders and granules orodispersible preparations chewable preparations liquid preparations solid preparations, including mini-tablets	EMA, Swissmedic, U.K. MHRA, U.S. FDA	July 15, 2026
L03AA – colony stimulating factors under the ATC classification	1. Subject to applicable exceptions in (1.1), when the indications include an indication for pediatric populations 1.1 When the drug referred to in article 1 is listed in Schedule D to the Food and Drugs Act and is subject to a submission seeking a notice of compliance on the basis of a direct or indirect comparison between the drug subject to the submission and another drug that is authorized to be sold in Canada	1. EMA, Swissmedic, U.K. MHRA, U.S. FDA 1.1 no applicable foreign regulatory authority	July 15, 2026
M01AE01 – ibuprofen under the ATC classification	When the preparation is Ibuprofen lysine and meets all the following: formulated to be administered via injection indicated to close clinically significant patent ductus arteriosus in premature infants	EMA, Swissmedic, U.K. MHRA, U.S. FDA	July 15, 2026
N03AX – other antiepileptics under the ATC classification	1. Subject to applicable exceptions in (1.1), when the indications include an indication for pediatric populations and is in any of the following drug formats: oral preparations: powders and granules orodispersible preparations chewable preparations liquid preparations oromucosal preparations solid preparations, including mini-tablets capsules nasal preparations cutaneous preparations transdermal preparations 1.1 When the drug referred to in article 1 is a cell therapy, gene therapy, RNAi-based therapy or tissue engineered product	1. EMA, Swissmedic, U.K. MHRA, U.S. FDA 1.1 EMA, U.S. FDA	July 15, 2026
P02CA03 – albendazole under the ATC classification	When the indications include an indication for pediatric populations and is in any of the following drug formats: oral preparations: powders and granules orodispersible preparations chewable preparations liquid preparations oromucosal preparations solid preparations, including mini-tablets capsules	EMA, Swissmedic, TGA, U.K. MHRA, U.S. FDA	July 15, 2026
S01FA54 – cyclopentolate, combinations under the ATC classification	When combined with phenylephrine and meets the following: indicated for use for the production of mydriasis	EMA, Swissmedic, U.K. MHRA, U.S. FDA	July 15, 2026
V03AF09 – glucarpidase under the ATC classification	When the indications include an indication for pediatric populations	EMA, Swissmedic, U.K. MHRA, U.S. FDA	July 15, 2026

Division 2
120-day filing

Drug class	Qualifiers	Foreign regulatory authorities	Effective date
None	-	-	-

Division 3
Joint review

Drug class	Qualifiers	Foreign regulatory authorities	Effective date
A drug that falls within the following groups described in accordance with the anatomical therapeutic chemical (ATC) classification system: A - alimentary tract and metabolism B - blood and blood forming organs C - cardiovascular system D - dermatologicals G - genito urinary system and sex hormones H - systemic hormonal preparations, excluding sex hormones and insulins J - antiinfectives for systemic use L - antineoplastic and immunomodulating agents M - musculo-skeletal system N - nervous system P - antiparasitic products, insecticides and repellents R - respiratory system S - sensory organs V – various	-	HSA, Swissmedic, TGA, U.K. MHRA	July 15, 2026

Drug class

Qualifiers

Foreign regulatory authorities

Effective date

A drug that falls within the following groups described in accordance with the anatomical therapeutic chemical (ATC) classification system:

A - alimentary tract and metabolism
B - blood and blood forming organs
C - cardiovascular system
D - dermatologicals
G - genito urinary system and sex hormones
H - systemic hormonal preparations, excluding sex hormones and insulins
J - antiinfectives for systemic use
L - antineoplastic and immunomodulating agents
M - musculo-skeletal system
N - nervous system
P - antiparasitic products, insecticides and repellents
R - respiratory system
S - sensory organs
V – various

HSA, Swissmedic, TGA, U.K. MHRA

July 15, 2026

Part 2: Abbreviated new drug submissions (ANDS) for human drugs

General deeming
Drug class	Qualifiers	Foreign Regulatory Authorities	Effective date
None	-	-	-

Part 3: Supplements to drug submissions for human drugs

Includes:

Supplements to new drug submissions (SNDS)
Supplements to abbreviated new drug submissions (SANDS)

Division 1,
Subdivision 1
General deeming:
SNDS

Drug class	Qualifiers	Foreign regulatory authorities	Effective date
A drug that falls within the following groups described in accordance with the anatomical therapeutic chemical (ATC) classification system: A - alimentary tract and metabolism B- blood and blood forming organs C - cardiovascular system D - dermatologicals G - genito urinary system and sex hormones H - systemic hormonal preparations, excluding sex hormones and insulins J – antiinfectives for systemic use L - antineoplastic and immunomodulating agents M - musculo-skeletal system N - nervous system P - antiparasitic products, insecticides and repellents R - respiratory system S - sensory organs V – various	1. Subject to applicable exceptions in (1.1) to (1.14), when the supplement includes an indication for pediatric populations 1.1 When the drug referred to in article 1 contains a substance included in any of Schedules I to VI to the Controlled Drugs and Substances Act and is currently indicated for use in pediatric populations 1.2 When the drug referred to in article 1 is a cell therapy, gene therapy, RNAi-based therapy or tissue engineered product 1.3 When the drug referred to in article 1 is a synthetic peptide 1.4 When the drug referred to in article 1 falls within ATC classification a J06A - immune sera 1.5 When the drug referred to in article 1 falls within ATC classification J06B - immunoglobulins 1.6 When the drug referred to in article 1 falls within ATC classification B01AB02 - antithrombin III 1.7 When the drug referred to in article 1 falls within ATC classification B05A - blood and related products 1.8 When the drug referred to in article 1 falls within ATC classification B02BB fibrinogen 1.9 When the drug referred to in article 1 falls within ATC classification B02BD - blood coagulation factors 1.10 When the drug referred to in article 1 falls within ATC classification B06AB - heme products 1.11 When the drug referred to in article 1 falls within ATC classification B06AC01 - c1-inhibitor, plasma derived 1.12 When the drug referred to in article 1 falls within ATC classification J07 - vaccines 1.13 When the drug referred to in article 1 is a vaccine that falls within ATC classification L03AX - other immunostimulants 1.14 When the drug referred to in article 1 is listed in Schedule D to the Food and Drugs Act and is subject to a submission seeking a notice of compliance on the basis of a direct or indirect comparison between the drug subject to the submission and another drug that is authorized to be sold in Canada	1. EMA, Swissmedic, U.K. MHRA, U.S. FDA 1.1 EMA, Swissmedic, U.K. MHRA, U.S. FDA 1.2 EMA, U.S. FDA 1.3 U.S. FDA 1.4 U.S. FDA 1.5 U.S. FDA 1.6 U.S. FDA 1.7 U.S. FDA 1.8 U.S. FDA 1.9 U.S. FDA 1.10 U.S. FDA 1.11 U.S. FDA 1.12 no applicable foreign regulatory authority 1.13 no applicable foreign regulatory authority 1.14 no applicable foreign regulatory authority	July 15, 2026

Drug class

Qualifiers

Foreign regulatory authorities

Effective date

A drug that falls within the following groups described in accordance with the anatomical therapeutic chemical (ATC) classification system:

A - alimentary tract and metabolism
B- blood and blood forming organs
C - cardiovascular system
D - dermatologicals
G - genito urinary system and sex hormones
H - systemic hormonal preparations, excluding sex hormones and insulins
J – antiinfectives for systemic use
L - antineoplastic and immunomodulating agents
M - musculo-skeletal system
N - nervous system
P - antiparasitic products, insecticides and repellents
R - respiratory system
S - sensory organs
V – various

1. Subject to applicable exceptions in (1.1) to (1.14), when the supplement includes an indication for pediatric populations
- 1.1 When the drug referred to in article 1 contains a substance included in any of Schedules I to VI to the Controlled Drugs and Substances Act and is currently indicated for use in pediatric populations
- 1.2 When the drug referred to in article 1 is a cell therapy, gene therapy, RNAi-based therapy or tissue engineered product
- 1.3 When the drug referred to in article 1 is a synthetic peptide
- 1.4 When the drug referred to in article 1 falls within ATC classification a J06A - immune sera
- 1.5 When the drug referred to in article 1 falls within ATC classification J06B - immunoglobulins
- 1.6 When the drug referred to in article 1 falls within ATC classification B01AB02 - antithrombin III
- 1.7 When the drug referred to in article 1 falls within ATC classification B05A - blood and related products
- 1.8 When the drug referred to in article 1 falls within ATC classification B02BB fibrinogen
- 1.9 When the drug referred to in article 1 falls within ATC classification B02BD - blood coagulation factors
- 1.10 When the drug referred to in article 1 falls within ATC classification B06AB - heme products
- 1.11 When the drug referred to in article 1 falls within ATC classification B06AC01 - c1-inhibitor, plasma derived
- 1.12 When the drug referred to in article 1 falls within ATC classification J07 - vaccines
- 1.13 When the drug referred to in article 1 is a vaccine that falls within ATC classification L03AX - other immunostimulants
- 1.14 When the drug referred to in article 1 is listed in Schedule D to the Food and Drugs Act and is subject to a submission seeking a notice of compliance on the basis of a direct or indirect comparison between the drug subject to the submission and another drug that is authorized to be sold in Canada

1. EMA, Swissmedic, U.K. MHRA, U.S. FDA
- 1.1 EMA, Swissmedic, U.K. MHRA, U.S. FDA
- 1.2 EMA, U.S. FDA
- 1.3 U.S. FDA
- 1.4 U.S. FDA
- 1.5 U.S. FDA
- 1.6 U.S. FDA
- 1.7 U.S. FDA
- 1.8 U.S. FDA
- 1.9 U.S. FDA
- 1.10 U.S. FDA
- 1.11 U.S. FDA
- 1.12 no applicable foreign regulatory authority
- 1.13 no applicable foreign regulatory authority
- 1.14 no applicable foreign regulatory authority

July 15, 2026

Division 1,
Subdivision 2:
General deeming:
SANDS

Drug class	Qualifiers	Foreign regulatory authorities	Effective date
None	-	-	-

Division 2,
120-day filing:
SNDS

Drug class	Qualifiers	Foreign regulatory authorities	Effective date
None	-	-	-

Division 3,
Joint review: SNDS

Drug class	Qualifiers	Foreign regulatory authorities	Effective date
A drug that falls within the following groups described in accordance with the anatomical therapeutic chemical (ATC) classification system: A - alimentary tract and metabolism B - blood and blood forming organs C - cardiovascular system D - dermatologicals G - genito urinary system and sex hormones H - systemic hormonal preparations, excluding sex hormones and insulins J - antiinfectives for systemic use L - antineoplastic and immunomodulating agents M - musculo-skeletal system N - nervous system P - antiparasitic products, insecticides and repellents R - respiratory system S - sensory organs V – various	-	HSA, Swissmedic, TGA, U.K. MHRA	July 15, 2026

Drug class

Qualifiers

Foreign regulatory authorities

Effective date

A drug that falls within the following groups described in accordance with the anatomical therapeutic chemical (ATC) classification system:

A - alimentary tract and metabolism
B - blood and blood forming organs
C - cardiovascular system
D - dermatologicals
G - genito urinary system and sex hormones
H - systemic hormonal preparations, excluding sex hormones and insulins
J - antiinfectives for systemic use
L - antineoplastic and immunomodulating agents
M - musculo-skeletal system
N - nervous system
P - antiparasitic products, insecticides and repellents
R - respiratory system
S - sensory organs
V – various

HSA, Swissmedic, TGA, U.K. MHRA

July 15, 2026

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List of classes of drugs and foreign regulatory authorities for the purposes of reliance on decisions or documents (IbR List): Human drugs

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About the IbR List

The IbR List

Part 1: New drug submissions (NDS) for human drugs

Part 2: Abbreviated new drug submissions (ANDS) for human drugs

Part 3: Supplements to drug submissions for human drugs

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