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Filing a New Drug Submission (NDS) or Abbreviated New Drug Submission (ANDS) with Health Canada is one of the more complex regulatory processes a drug company can undertake in Canada. The documentation requirements are extensive, the review timelines are long, and gaps in your submission package can set your approval back by months.
We work with drug companies to prepare, file, and manage drug submissions from start to finish, so the process moves as efficiently as possible.
A New Drug Submission (NDS) is the pathway Health Canada uses to evaluate whether a new drug product is safe, effective, and of acceptable quality before it can be sold in Canada. It applies to new pharmaceutical products, new formulations of existing drugs, and new indications for previously approved drugs. A successful NDS results in a Notice of Compliance (NOC) and, subsequently, a Drug Identification Number (DIN).
An Abbreviated New Drug Submission (ANDS) is the equivalent pathway for generic drug products. Rather than providing the full clinical evidence required for a new drug, the ANDS demonstrates that the generic product is bioequivalent to a Canadian Reference Drug (CRD) that has already been approved. A successful ANDS also results in a NOC and DIN, allowing the generic product to enter the Canadian market.
Both pathways involve significant documentation: chemistry and manufacturing information, preclinical and clinical data, labelling, and evidence of bioequivalence or clinical efficacy depending on the submission type. Health Canada’s review process is thorough, and submissions that arrive incomplete or with inconsistencies typically receive a Notice of Deficiency that extends the timeline. Preparing a well-structured, complete submission is the most effective way to move through review without unnecessary delays.
New Drug Submission (NDS)
An NDS is required when you are introducing a drug product that does not yet have a Canadian Reference Drug equivalent. This includes new molecular entities, new drug products with novel formulations, new dosage forms, new routes of administration, and new therapeutic indications. NDS submissions require full clinical and preclinical evidence to establish safety and efficacy.
Abbreviated New Drug Submission (ANDS)
An ANDS applies when you are seeking approval for a generic drug product that is therapeutically equivalent to a drug already approved and marketed in Canada. Rather than repeating the full clinical trial program, an ANDS demonstrates bioequivalence to the Canadian Reference Drug through comparative bioavailability studies. The review process is generally shorter than an NDS, but the documentation requirements are still substantial.
Not Sure Which One You Need?
The right pathway depends on your product, its ingredients, its intended indications, and whether a suitable Canadian Reference Drug exists. We can review your product and tell you exactly which submission type applies and what the process looks like before you commit to a path.
Before any documentation is prepared, we assess your product, its intended Canadian market positioning, and the regulatory history of comparable products. We determine the correct submission type, identify the Canadian Reference Drug if applicable, map out the full documentation requirements, and give you a realistic picture of the timeline and process. Starting with a clear plan prevents the mid-submission course corrections that extend timelines and add cost.
We prepare the complete submission package for your NDS or ANDS. This includes the chemistry and manufacturing (CMC) section, comparative bioavailability study protocols and reports, preclinical and clinical summaries, product monograph, labelling, and all administrative components required by Health Canada’s Common Technical Document (CTD) format. Every section is reviewed for completeness and consistency before filing, because deficiencies in one area often trigger scrutiny of others.
Canadian drug labelling has specific requirements that differ from US FDA or EU standards. Your product monograph, inner and outer labels, and patient information materials must meet Health Canada’s bilingual requirements, format standards, and content guidelines. We review and prepare labelling as part of the submission, and flag any claims or formatting issues that could generate a label-related deficiency notice.
We manage the filing process directly, including submission to Health Canada’s drug review portal, fee payment coordination, and communication with Health Canada reviewers throughout the review period. If Health Canada issues a Notice of Deficiency or a request for clarification, we prepare the response and supporting documentation on your behalf. You are kept informed at each stage without having to manage the regulatory back-and-forth yourself.
Receiving your NOC and DIN is the beginning of an ongoing compliance relationship with Health Canada, not the end of the process. Post-market commitments, label amendments, formulation changes, new indication submissions, and annual reporting obligations all require attention after approval. We support the full product lifecycle so your DIN remains in good standing and any changes to your product are handled through the correct regulatory pathway.
Health Canada’s standard review target for a Priority Review NDS is 180 days, and for a standard NDS it is 300 days, measured from the date Health Canada accepts the submission as complete. That clock does not start until your submission passes the screening phase, which adds additional time. In practice, total elapsed time from initial filing to NOC issuance often runs longer, particularly if a Notice of Deficiency is issued. A well-prepared, complete submission at first filing is the most effective way to keep the timeline as short as possible.
A Canadian Reference Drug is the innovator product that Health Canada uses as the comparator for evaluating generic drug submissions. For an ANDS to proceed, a CRD must exist for your product’s active ingredient, dosage form, and strength. If no CRD has been designated, Health Canada may not accept the ANDS. We verify CRD status as part of our initial assessment before any documentation work begins.
FDA approval does not automatically qualify your product for the Canadian market. Health Canada conducts its own independent review, and while prior approval by a recognized regulatory authority can inform Health Canada’s assessment, a full NDS or ANDS submission is still required. We work with companies that have US-approved products and help them adapt their existing documentation packages to meet Health Canada’s CTD requirements and Canadian-specific labelling standards.
A Notice of Deficiency (NOD) is Health Canada’s formal notification that your submission has gaps or issues that must be addressed before the review can continue. Responding to an NOD requires submitting a detailed response package that directly addresses each deficiency, with supporting data or documentation. Response timelines are fixed, and an inadequate response can result in a refusal. We prepare NOD responses on behalf of our clients and manage the submission of the response package to Health Canada.
A comparative bioavailability (bioequivalence) study is a clinical study that demonstrates your generic product releases its active ingredient into the bloodstream at the same rate and extent as the Canadian Reference Drug. The study must meet Health Canada’s bioequivalence guidance, including specific statistical criteria (generally a 90% confidence interval within 80 to 125% for key pharmacokinetic parameters). The study protocol, data, and analysis form a core part of your ANDS submission. We review bioequivalence study designs and results as part of the submission preparation process.
Health Canada charges submission fees that vary based on the submission type and review category. Our consulting fees depend on the scope of work, the complexity of your product, and whether your existing documentation package requires significant adaptation for Canadian requirements. We review your situation in an initial consultation and give you a clear picture of the regulatory fees and our scope before any work begins.
DIN Application
For OTC and prescription drug products that follow a monograph pathway rather than a full NDS, we manage the DIN application process directly.
Drug Establishment Licence (DEL)
Before your drug product can be sold in Canada, your facility and its activities must be authorized under a DEL. We support the full application, GMP compliance, and annual renewal process.
OTC Drugs & Controlled Substances Hub
An overview of all our Health Canada drug compliance services, including DIN applications, DEL registration, and psychedelics compliance.
Whether you are planning an NDS, preparing an ANDS, or trying to understand which pathway applies to your product, we can help you map out the right next steps.