SFDA Guidance: Requirements for Formal Meetings Between the Drug Sector and Applicants

The Saudi Food and Drug Authority (SFDA) has issued an updated version (3.1, dated 7 April 2025) of its guideline: "Requirements for Formal Meetings Between the Drug Sector and Applicants." This document outlines the framework for submitting and managing formal meeting requests between pharmaceutical applicants and SFDA's Drug Sector. It is designed to streamline communication, promote regulatory clarity, and ensure that meetings are productive and scientifically valuable.

Formal Meeting: A structured interaction in which an applicant requests to discuss regulatory, scientific, or procedural topics. The SFDA’s Drug Sector provides applicants with an official mechanism to request meetings for scientific, regulatory, pricing, or product-specific discussions.

This structured process helps ensure that:

• Meeting topics are clearly defined.

• Relevant SFDA departments are involved.

• All necessary documents are shared in advance.

• Timelines and expectations are transparent.

There are three forms provided in the guidance to cater to different needs:

1. Form A – General Meetings Used for high-level or cross-departmental queries.

   Required details: applicant info, purpose, agenda, participants, preferred format (physical/virtual), and proposed timing.

2. Form B – Pricing & Pharmacoeconomics Meetings. For meetings focused on drug pricing, reimbursement strategies, or pharmacoeconomic justifications.

   Includes product and pricing details, registration numbers, and proposed price changes.

3. Form C – Scientific/Regulatory Meetings for Specific Products. Used when scientific advice or regulatory consultation is needed for a specific drug.

   Includes product status, development stage, regulatory designation, and prior advice from SFDA or other agencies.

Meetings are recommended for:

• Pre-submission queries (e.g., clinical trial protocols, marketing authorization applications).

• Complex regulatory pathways (e.g., orphan drugs, breakthrough therapies).

• Pricing appeals or pharmacoeconomic evaluations.

• Post-submission issues (e.g., variations, renewals, safety updates).

How to Request a Meeting

Step 1: Prepare Your Request

Submit a Meeting Request Form (Form A, B, or C) via email to Drug.VP@sfda.gov.sa, including:

1. Applicant Information: Contact name, title, email, phone number, and organization.

2. Purpose & Objectives: Clear description of topics (e.g., product-specific advice, pricing strategy).

3. Agenda & Questions: Proposed discussion points with context.

4. Participant List: Names and titles of attendees from the applicant’s side.

5. Meeting Type:

   • Face-to-face (SFDA office in Riyadh).

   • Remote (video/teleconference – connection details must be shared in advance).

6. Attachments: Supporting documents (e.g., PowerPoint slides, clinical data, pricing proposals).

7. Suggested Date/Time: Three options between 9:00 AM and 2:00 PM (Sunday–Thursday).

   
   

SFDA’s Assessment Process

1. Initial Review: The Drug Sector evaluates the request within 5 working days.

2. Outcomes:

   • Accepted: The SFDA confirms the date, time, and attendees.

   • Rejected: A justification is provided (e.g., incomplete information, topic covered in existing guidelines).

3. Rescheduling/Cancellation:

   • Applicants must notify the SFDA promptly.

   • Missed meetings require a new request.

Whether you're preparing a product launch, exploring pricing models, or requesting development advice, following this guide ensures regulatory alignment and timely progress.

For the full document, 👉 Download: Requirements for Formal Meeting with SFDA Drug Sector (PDF)