The Saudi Food and Drug Authority (SFDA) has released an updated version of its guideline on formal meetings between the Drug Sector and applicants. This latest update, Version 3.1, published in April 2025, aims to streamline communication, improve efficiency, and ensure transparency in regulatory interactions.

Purpose of the Guideline

Formal meetings are a critical component of regulatory collaboration, providing applicants with the opportunity to seek clarification, present information, and discuss product-related or procedural matters directly with SFDA experts. The guideline defines a formal meeting as any meeting requested by an applicant following SFDA’s established request procedures.

Key Requirements for Meeting Requests

• Applicant information: Contact person’s name, phone, and email.
• Purpose and objectives: A clear statement outlining meeting goals and discussion topics.
• Proposed agenda: Structured points for discussion.
• List of questions: With full context and objectives.
• Participants list: Including names and titles of all attendees from the applicant’s organization.
• Meeting format: Face-to-face, virtual, or hybrid (with advance provision of connection details if remote).
• Executive directorate requested: Relevant SFDA departments to be present.
• Supporting documents: Such as background materials, data, or presentations.
• Suggested date and time: Between 09:00 a.m. and 2:00 p.m., Sunday to Thursday.

For meetings involving the Pricing & Pharmacoeconomics Directorate, applicants must complete a B Form. For product-specific meetings, a C Form is required.

Assessment of Requests

• Acceptance: Meeting details (date, time, place) are provided by email. Applicants must confirm attendance, otherwise the meeting is cancelled.
• Denial: Applicants receive a justification for rejection.
• Rescheduling/Cancellation: Applicants must notify SFDA promptly to avoid delays. A cancelled meeting requires a new request.

Meeting Procedure

• Meetings are managed by SFDA staff based on the approved agenda.
• Applicants are expected to follow the agreed structure; failure to comply may result in cancellation.
• Before the meeting concludes, both parties should summarize key discussion points, agreements, and clarifications to ensure alignment.

Why This Matters for Regulatory Professionals

• Structured and efficient communication with SFDA.
• Greater predictability in regulatory interactions.
• Improved collaboration through clear agendas and documented discussions.
• Faster resolution of regulatory queries by engaging the right SFDA experts.

By following these requirements, applicants can maximize the value of formal meetings and minimize procedural delays, supporting smoother regulatory pathways for their products in Saudi Arabia.