What is an ANDS?
An Abbreviated New Drug Submission is the Canadian regulatory filing route for generic drug products. Health Canada accepts it under Food and Drug Regulations section C.08.002.1. Functionally it is the Canadian equivalent of the FDA ANDA.
Short answer. An ANDS is a generic-drug submission to Health Canada, governed by Food and Drug Regulations C.08.002.1. It uses the CTD format, with bioequivalence data in Module 5 replacing full clinical efficacy. Module 3 CMC content is fully characterized; safety and efficacy cross-reference the Canadian Reference Product.
Statutory basis
The ANDS pathway is codified in the Food and Drug Regulations (C.R.C., c. 870), section C.08.002.1. A sponsor files an ANDS when introducing a generic version of an innovator product that holds a Notice of Compliance (NOC). The Patented Medicines (Notice of Compliance) Regulations (PMNOC) govern patent-linked rights and the ANDS/NOC review process.
What must be demonstrated
- Pharmaceutical equivalence: same active ingredient(s), same route of administration, same dosage form, same strength.
- Bioequivalence: equivalent rate and extent of absorption compared to the Canadian Reference Product, demonstrated per Health Canada's Conduct and Analysis of Comparative Bioavailability Studies guidance.
- Chemistry and manufacturing equivalence: full Module 3 CMC content including 3.2.S drug substance, 3.2.P drug product, stability per ICH Q1A(R2), impurity profile per ICH Q3A(R2) / Q3B(R2), specifications per ICH Q6A.
- Labeling: Canadian Product Monograph aligned with the innovator's approved labeling.
Related filing types
- NDS (New Drug Submission). Full new drug filing for innovator products.
- SNDS (Supplemental New Drug Submission) or SANDS (Supplemental ANDS). Post-approval changes of sufficient magnitude to require full review.
- Notifiable Change. Moderate changes communicated to Health Canada with a 90-day holding period before implementation.
- Annual Notification. Low-impact changes reported annually.
Relationship to US and EU generics
- FDA ANDA (21 CFR 314.94) is the US equivalent. Both use CTD format.
- EMA generic procedure (Directive 2001/83/EC Article 10) is the EU equivalent. Abridged application citing the reference medicinal product.
- Core Module 3 content authored to ICH M4Q(R2) is largely portable between the three jurisdictions with region-specific Module 1 administrative wrappers.
Related glossary entries
Frequently asked questions
What is an ANDS?
An Abbreviated New Drug Submission is how generic products are filed with Health Canada. Governed by Food and Drug Regulations C.08.002.1. Allows a sponsor to reference the innovator's safety and efficacy data while demonstrating bioequivalence and CMC equivalence.
How is ANDS different from ANDA?
ANDA is the US FDA equivalent filed under 21 CFR 314.94. Both are CTD-format generic filings. Core Module 3 content is largely interchangeable.
What does an ANDS require?
CTD Modules 1-5, with bioequivalence data replacing full Phase III efficacy reports. Module 3 (CMC) fully characterizes the drug substance and product. Safety and efficacy reference the Canadian Reference Product under PMNOC.
What about post-approval changes?
Post-NOC changes follow Health Canada's Changes guidance. SANDS for major changes, Notifiable Change for moderate, Annual Notification for minor.