Abbreviated New Drug Submission (ANDS) is the application submitted to Health Canada for review and approval of generic drugs against the Canadian Reference Product (CRP).
Following the review of an ANDS by the Health Canada, provided the information is sufficient to support the safety, efficacy and quality of the drug, Notice of Compliance (NOC) and Drug Identification Number (DIN) are issued to the applicants for commercialization of the drug in Canada.
The drug registration process in Canada has similarities to those of both the United States Food and Drug Administration (USFDA) and European Medicines Agency (EMA). However, the unique procedural and specific technical requirements of Health Canada demands to have a Regulatory expert with experience to handle registration activities with Health Canada. Complete understanding of typical procedural requirements like Drug Establishment License (DEL) and others will be critical for quicker registration and approval.
Freyr has extensive experience and expertise to support clients with the preparation, review, and submission of Abbreviated New Drug Submissions (ANDS) to Health Canada.
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