Canada Health Authority Interactions - Overview
Regulatory agency interactions are key in achieving a positive impact on the approval timelines and overall costs. Since the final decision on drug product approvals lies with Health Canada, it is important to ensure that the interactions with the Agency (whether face-to-face, in writing, or via teleconference) are conducted efficiently throughout the Regulatory process.
Sponsors can request Canada Health Authority interactions to understand the bioequivalence study design and other expectations for the content, format, and level of information required to be included in the pre-submission meetings. Health Canada provides generic applicants with an opportunity to discuss and clarify the expectations of the development plans and meetings to help applicants identify the potential risks and issues related to their ANDS applications so that the appropriate risk-mitigation strategies can be implemented to minimize the approval time.
Freyr, with expertise in handling end-to-end registration activities and Canada Health Authority interactions, can assist applicants in all types of formulations, Regulatory submissions, procedural guidance, and understanding the concerns along with the compilation of appropriate responses with scientific justification to avoid further queries.
Canada Health Authority Interactions - Freyr Expertise
Pre-submission communications with Health Canada (HC) to confirm the formulation of the drug product.
Preparation of meeting packages, documents, meeting plans, meeting minutes, and communication results in alignment with HC guidelines.
Requesting scientific advice from HC before the ANDS application submission.
Implementation of relevant meeting strategy that covers the overall objectives and fulfills the meeting’s goal.
Follow-up activities and post-meeting requirements like the submission of meeting minutes and development of program strategy based on Health Authority interactions.
Evaluate the queries and formulate appropriate responses to them.
CCompilation of scientific justification in case of rejection of pre-submission meeting requests.
Correspondence with HC on day-to-day activities for clarifications on a submission strategy.