Pre‑ANDS Meeting (Health Canada)

Navigating the Health Canada regulatory landscape can be complex—especially when preparing an Abbreviated New Drug Submission (ANDS). One of the most effective ways to ensure your application is robust and aligns with Health Canada’s expectations is by requesting a Pre‑ANDS meeting. These meetings offer a strategic opportunity to clarify requirements, flag potential issues, and streamline your path to approval.

What is a Pre‑ANDS Meeting?

A Pre‑ANDS meeting (also known as a pre‑submission or pre‑application meeting) is a formal consultation between a drug sponsor and Health Canada’s review staff before filing an ANDS. It involves direct interaction—via teleconference or in‑person—with review experts to discuss your drug development program, data plan, and regulatory strategy.

These meetings are an invaluable tool to:
  • Introduce your product to Health Canada reviewers
  • Present your data and technical approach
  • Identify and resolve potential issues proactively
  • Determine eligibility for special pathways (e.g., priority review or NOC/c)

Why Are Pre‑ANDS Meetings Important?

  1. Improved Submission Quality
    2. By reviewing your proposed data package in advance, Health Canada can guide you on study design, clinical comparability, and regulatory expectations—leading to a stronger ANDS.
  1. Early Risk Mitigation
    2. Potential issues—such as missing data, methodology gaps, or CMC concerns—can be flagged early. Addressing these upfront saves time and resources down the line
  1. Efficient Regulatory Pathway Planning
    2. Discussions on eligibility for priority review or NOC/c status can help align your submission timing and activities with desirable regulatory targets
  1. Enhanced Sponsor–Regulator Dialogue
    2. These meetings foster collaborative communication, increasing understanding and trust between your team and Health Canada reviewers.

How to Request a Pre‑ANDS Meeting

Health Canada provides clear guidance on how to coordinate a successful pre‑submission meeting
Step 1: Pre‑Meeting Contact

Get in touch with the relevant Director of the review Centre/Bureau/Office to discuss the appropriateness of a pre‑ANDS meeting.

Step 2: Formal Meeting Request (~3 Months Prior)

Submit a meeting request package at least three months before your desired meeting date. Documents should include:

  • Administrative cover letter
  • Clear meeting purpose (e.g., pre‑ANDS strategy)
  • Product details (active ingredient, dosage form, therapeutic class; note if it’s first‑in‑class)
  • Preliminary questions
  • Submission status (control number, product name)
  • Availability options (three preferred dates/times)
  • Suggested expertise needed from reviewers (clinical, CMC, biostatistics, etc.)

Requests must be submitted electronically in eCTD or non‑eCTD electronic formats via the Common Electronic Submissions Gateway

Step 3: Submit a Meeting Package (~1 Month Prior)
One month before the meeting, submit:
  • Cover letter and proposed agenda
  • Brief slide deck (submit one week before)
  • Summaries of product, indication, dosage, and clinical development plan
  • Safety/efficacy data summary
  • Manufacturing process overview
  • Foreign regulatory status and market history
  • List of specific questions/issues by discipline
  • Expected submission date
Step 4: Post‑Meeting Actions

Within two weeks after the meeting, submit meeting minutes summarizing discussions, responses, and action items. Reference the pre‑meeting control number and minutes in your final ANDS cover letter—showing alignment between what was agreed and what is submitted.

How Masuu Global Can Help You

At Masuu Global Quality and Regulatory Consultants, we help pharmaceutical companies prepare, conduct, and leverage Pre‑ANDS meetings to ensure success. Our services include:

  • Strategic planning and timing for meetings
  • Preparation of high-quality meeting packages in eCTD format
  • Drafting targeted questions and agendas tailored to regulatory objectives
  • Facilitation during meetings with Health Canada
  • Drafting and submitting meeting minutes
  • Ensuring ANDS process aligns with meeting outcomes and request timelines

With our deep expertise in Health Canada’s processes and expectations, we help you optimize regulatory dialogue and reduce approval risks.

Frequently Asked Questions

A Pre-ANDS meeting is a formal discussion between a pharmaceutical sponsor and Health Canada before submitting an Abbreviated New Drug Submission (ANDS). It provides an opportunity to discuss the proposed regulatory strategy, data package, and key technical requirements with Health Canada reviewers.

A Pre-ANDS meeting helps identify potential data gaps, CMC concerns, study requirements, and regulatory issues before the ANDS is filed. Addressing these points early can improve submission quality and reduce the risk of avoidable review delays.

Sponsors can discuss areas such as product development, clinical comparability, quality and manufacturing information, proposed studies, regulatory strategy, and submission planning. Specific questions can also be directed to relevant disciplines such as clinical, CMC, and biostatistics.

Sponsors should plan the meeting well in advance of the intended ANDS submission. Based on the applicable Health Canada process, a formal meeting request is generally prepared around three months before the desired meeting date to allow sufficient time for coordination and review.

The request generally includes an administrative cover letter, meeting purpose, product details, preliminary questions, submission information, preferred meeting dates, and the areas of expertise required from Health Canada reviewers. The package should clearly explain what guidance the sponsor is seeking.

The meeting package can include the proposed agenda, product and indication overview, dosage information, clinical development summary, safety and efficacy information, manufacturing details, foreign regulatory history, specific questions, and the expected ANDS submission timeline.

Questions should be clear, specific, and focused on decisions or guidance needed from Health Canada. Well-structured questions help reviewers understand the sponsor’s concerns and make the meeting more productive.

Following the meeting, the sponsor should document the discussion, including Health Canada’s responses, key decisions, and agreed action items. The meeting outcomes can then be considered when finalizing the ANDS and its supporting documentation.

Masuu Global can support the complete process, including meeting strategy and timing, meeting request preparation, eCTD documentation, agendas, regulatory questions, presentation materials, and meeting facilitation. We also help ensure that the final ANDS reflects the relevant meeting outcomes.

By engaging with Health Canada before submission, sponsors can gain greater clarity around regulatory expectations and identify potential issues at an early stage. This proactive approach can help strengthen the ANDS, improve submission readiness, and support a more efficient review process.

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