ANDA Post-approval Change Submissions - Overview
ANDA post-approval changes must be submitted to Health Canada (HC) as a supplement/amendment/annual report based on the complexity and impact on the quality of the product as per the HC guidelines.
Based on the impact of the change, the reporting categories of the Canada ANDA post-approval changes are as follows:
- Level I - Supplements (Major changes).
- Level II - Notifiable Changes (Moderate Quality Changes).
- Level III - Annual Notification (Minor Quality Changes).
- Level IV - Record of changes.
The criteria, supporting documents/data required, and implementation timelines differ for each ANDA post-approval change and hence, expertise is needed for the assessment of the change, development of strategies, and submission of supplement/amendment/annual report.
ANDA Post-approval Change Submissions - Expertise
- Preparation, submission, and review of the ANDA post-approval changes submissions.
- DIN/ANDS/MF holder transfers.
- Review and submission of the supplement/amendment for changes in the manufacturing sites, batch sizes or formulation, routes of synthesis, equipment, container closure systems, specifications, test methods, and shelf life.
- Inclusion of additional sources for the starting materials of the drug substances.
- Assessment of the reporting category and supporting documents.
- Evaluation of the proposed changes in accordance with the Health Authority guidelines.
- Tracking of the due date for annual reports of the ANDA post-approval changes.
- Gap analysis, preparation, and submission of supplement/amendment/annual report.
- Preparation of a relevant Regulatory strategy for an ANDA post-approval change submission.
- Interaction and follow-up with the HC for the review or approval of the submitted changes.
