The Saudi Food and Drug Authority (SFDA) has issued Version 3.1 of its Requirements for Formal Meetings between the Drug Sector and Applicants, providing updated guidance to ensure smooth communication and productive interactions between applicants and SFDA officials.

Purpose of the Policy

This document is designed to assist applicants in properly submitting requests for formal meetings with the Drug Sector. It aims to make the process more transparent, minimize delays, and ensure that SFDA allocates the appropriate resources and experts to address applicant inquiries.

Key Highlights of Version 3.1

• New Request Form: Introduced a dedicated request form for meetings with the Pricing & Pharmacoeconomics Directorate.
• Clarified Process: Reinforced the steps and timelines for submission, assessment, and confirmation of meeting requests.
• Structured Information: Required applicants to submit detailed agendas, questions, and supporting documents in advance for efficient discussion.

Information Required in a Meeting Request

1. Applicant Details: Contact person name, phone number, and email address.
2. Purpose & Objectives: A brief statement explaining the meeting’s goals and topics.
3. Proposed Agenda: Clearly outline discussion points.
4. List of Questions: Include context and purpose for each question.
5. Participant List: Names and titles of all representatives attending the meeting.
6. Type of Meeting: Indicate whether it is face-to-face or remote (video/teleconference).
7. Preferred Executive Directorate: Specify the directorate(s) requested to attend.
8. Supporting Documents: Attach all relevant files, including presentations.
9. Suggested Date & Time: Propose three options within working hours (Sunday to Thursday, 9:00 AM – 2:00 PM).

Applicants requesting a meeting with the Pricing & Pharmacoeconomics Directorate must complete the special B Form, while requests related to a specific product should use the C Form.

Assessment & Response Timeline

• Review Period: The Drug Sector reviews the request within five working days and informs the applicant by email.
• Acceptance: If accepted, SFDA provides the meeting date, time, and location. Applicants must confirm attendance by email.
• Denial: If denied, SFDA provides justification for the decision.
• Rescheduling: Applicants must promptly notify SFDA of any need to reschedule to allow proper adjustments.

Meeting Procedure

• The meeting will follow the submitted agenda and be chaired by the assigned SFDA representative.
• SFDA reserves the right to cancel the meeting if the applicant does not comply with the request requirements.
• Before closing, both parties should summarize key discussion points, agreements, and clarifications.

Importance of Proper Preparation

To avoid delays, applicants are encouraged to first check SFDA’s published guidelines on its website. Many common inquiries are already addressed in available regulatory documents.