Health Canada ANDS - Overview
Abbreviated New Drug Submission (ANDS) is the application submitted to Health Canada for the review and approval of generic drugs against the Canadian Reference Product (CRP).
Following the review of the Health Canada ANDS, a Notice of Compliance (NOC) and Drug Identification Number (DIN) are issued, provided the information is sufficient to support the safety, efficacy, and quality of the drug for its commercialization in Canada.
The drug registration process in Canada has similarities to those of the United States Food and Drug Administration (US FDA) and the European Medicines Agency (EMA). However, the unique procedural and specific technical requirements of Health Canada demand a Regulatory expert to handle the registration activities. A complete understanding of the typical procedural requirements like Drug Establishment License (DEL) and others are critical for quicker registration and approval.
Freyr has extensive experience in supporting clients with the preparation, review, and Abbreviated New Drug Submission (ANDS) pathways to Health Canada.
Health Canada ANDS - Freyr Expertise
Regulatory consultation during product development & manufacturing phase for selection of CRP, review of specifications for finished product/in-process controls/API, product development report, process validation protocol/report, stability study and batch size requirements.
Prepare/review of ANDS submission strategy and guidance on risk mitigation plans in line with Health Canada requirements.
Handling pre-submission meetings with Health Canada.
DEL application submission.
Providing checklist for Abbreviated New Drug Submission (ANDS) documents.
GAP analysis/Regulatory assessment of generated source data for Regulatory adequacy.
Guidance on the generation of additional/missing documents to comply with Health Canada. specific requirements.
Preparation of Abbreviated New Drug Submission (ANDS) package in line with current Health Canada requirements, publishing and submission in eCTD format.
Interaction/follow-ups with Health Canada for the ANDS approval.
Regulatory strategy and quick response preparation for HC queries.
Regulatory submission road map/filing procedure for ANDS and generating supporting documents.