Health Canada — HPFB Guidelines
Health Products and Food Branch (HPFB) — Canada's federal authority responsible for the regulation of pharmaceutical drugs, biologics, radiopharmaceuticals, genetic therapies, and natural health products.
300 Days
Standard NDS Review
180 Days
Priority Review
eCTD
Strictly Required
HPFB
Review Authority
NDS — New Drug Submission
A New Drug Submission (NDS) is the comprehensive regulatory application submitted to Health Canada's Health Products and Food Branch (HPFB) for authorisation of a new active substance not previously marketed in Canada. The NDS must contain sufficient scientific evidence to demonstrate that the drug is safe, efficacious, and of high quality for its intended use. Upon successful review, Health Canada issues a Notice of Compliance (NOC) and a Drug Identification Number (DIN), authorising the product for sale in Canada.
NDS Module Requirements
Module 1 — Administrative Information
Canadian-specific administrative data including the submission cover letter, product information (Product Monograph), labelling, and regulatory forms required by Health Canada.
Module 2 — Common Technical Document Summaries
Quality Overall Summary (QOS), nonclinical and clinical overviews and summaries per ICH CTD format.
Module 3 — Quality (CMC)
Complete chemistry, manufacturing, and controls documentation including drug substance characterisation, manufacturing process validation, specifications, stability data, and container closure systems.
Module 4 — Nonclinical Study Reports
Pharmacology, pharmacokinetics, and toxicology studies including single-dose toxicity, repeat-dose toxicity, genotoxicity, carcinogenicity, and reproductive toxicity studies.
Module 5 — Clinical Study Reports
Complete clinical data package including biopharmaceutic studies, pharmacokinetic studies, efficacy and safety data from Phase I through Phase III clinical trials, and post-market data if applicable.
ANDS — Abbreviated New Drug Submission
An Abbreviated New Drug Submission (ANDS) is the regulatory pathway for generic drug approvals in Canada. The ANDS relies on the safety and efficacy data established by the Canadian Reference Product (CRP) and focuses on demonstrating pharmaceutical equivalence and bioequivalence. This pathway significantly reduces the development cost and time compared to a full NDS, enabling broader patient access to affordable medicines.
ANDS Core Requirements
Pharmaceutical equivalence to the Canadian Reference Product (CRP)
Bioequivalence demonstrated through comparative bioavailability studies
Same active ingredient, strength, dosage form, and route of administration as the CRP
Chemistry and manufacturing documentation (Module 3) for the generic product
Comparative dissolution testing where applicable
Product Monograph aligned with the CRP labelling
Submission Types
eCTD Requirement
eCTD format is strictly required for all pharmaceutical, biological, and radiopharmaceutical drug submissions to Health Canada. All NDS, ANDS, supplements, and related regulatory activities must be submitted electronically in eCTD format through the Common Electronic Submissions Gateway (CESG). Non-eCTD submissions are no longer accepted.
Priority Review Eligibility
Health Canada offers expedited review pathways for drugs that demonstrate substantial clinical benefit over existing therapies for serious or life-threatening conditions. These pathways are designed to ensure patients gain timely access to critical therapies while maintaining rigorous safety and efficacy standards.
Serious or Life-Threatening Condition
The drug is intended to treat, prevent, or diagnose a serious or life-threatening disease or condition for which no existing therapy is available or for which the drug represents a significant improvement.
Substantial Clinical Evidence
There is substantial clinical evidence, based on at least one adequate well-controlled trial, that the drug provides a significant increase in efficacy or significant decrease in risk compared to existing marketed therapies.
NOC/c (Notice of Compliance with Conditions)
Health Canada may issue a conditional approval for promising therapies targeting serious conditions, requiring sponsors to undertake post-market confirmatory studies and submit additional data.
Priority Review Designation
Submissions granted Priority Review receive a reduced target review time of 180 days compared to the standard 300-day timeline, enabling faster access to critical therapies.
Key Regulations & Guidelines
Food and Drugs Act (R.S.C., 1985)
Primary Canadian legislation governing the sale, manufacture, and advertising of drugs and medical devices
Food and Drug Regulations (C.R.C., c. 870)
Comprehensive regulations under the Food and Drugs Act, including Division 8 (NDS) and Division 8.1 (ANDS)
Guidance: Preparation of Drug Regulatory Activities in eCTD
Health Canada guidance document outlining eCTD format requirements and technical specifications
ICH Guidelines (Health Canada adopted)
ICH Quality, Safety, and Efficacy guidelines as adopted by Health Canada
Patented Medicines (NOC) Regulations
Regulations governing the linkage between patent protection and drug approval for generic entry
Good Manufacturing Practices (GUI-0001)
Health Canada GMP guidelines for pharmaceutical manufacturing and quality systems
Reference Document
Health Canada eCTD User Guide
Official guidance for preparing and submitting eCTD-format regulatory dossiers to Health Canada
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