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Requirements

for Formal

Meeting between

SFDA and

Applicants

Version1.0

Date issued

04/12/2014

Date of implementation

01/01/2015

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[Requirements for Formal Meeting between SFDA and Applicants]

Version1.0

Drug Sector

Saudi Food & Drug Authority

Kingdom of Saudi Arabia

Please visit SFDA’s web site at http://www.sfda.gov.sa/En/Drug for

the latest update

Document Control

Version Date Author(s) Comments

1.0 04/12/2014 Executive Directorate of Product Evaluation and Standards Setting

Final

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Table of Contents

1. Introduction:.....................................................................................................................................5

2. Meeting Requests by Applicants:...................................................................................................5

3. Assessment of the meeting request:..............................................................................................6

4. Meeting Rescheduling or cancelling:.............................................................................................6

5. Meeting Procedure: ..........................................................................................................................6

Reference:..................................................................................................................................................7

Appendix 1: Application of meeting request……………………………….………………………………....……..…9

Appendix 2: Meeting response form..………………………………………………………………...……………………10

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1. Introduction: This guideline is provided by Saudi Food and Drug Authority (SFDA) in order to assist

applicants in the preparation and submission of meeting requests.

For the purposes of this guidance, formal meeting includes any meeting that is requested by a

sponsor or applicant following the request procedures provided in this guidance.

This guidance does not establish legally enforceable responsibilities. It represents the SFDA’s

current thinking on atopic and should be viewed only as recommendations.

2. Meeting Requests by Applicants:

To obtain the most efficient information from SFDA recourses and before seeking a meeting with

SFDA, the applicants should look for their concern which is probably stated in SFDA website

under the regulations section:

http://sfda.gov.sa/en/drug/drug_reg/Pages/drug_reg.aspx

If the meeting is still required and to prevent any delay that might occur, a written meeting

request should be submitted to drug vice president’s office via email (drug.vp@sfda.gov.sa). The

meeting request should include adequate information in order to assess the potential utility of the

meeting and to identify appropriate SFDA member (s) to discuss the proposed issues. The

meeting request should include the following information "appendix1":

1. Applicant name.

2. A brief statement of the purpose and objectives of the meeting. The statement should

include a summary of topics that the applicant is planning to discuss with SFDA

member (s) during the meeting. 3. A proposed agenda. 4. A list of proposed questions. For each question there should be a brief explanation of

the context and purpose of the question. 5. A list of participants in the meeting with their titles who will attend the meeting from

the applicant’s organization.

6. A list of SFDA departments requested by applicant to be presented in the meeting.

7. All supported documents related to the meeting request. 8. Suggested date and time of the meeting. The suggested times should be between

09:00 a.m. to 2:00 p.m. from Sunday to Thursday. The requested date and time is

not compulsory to SFDA and might be changed depending on the availability of

SFDA staff.

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3. Assessment of the meeting request:

After the meeting request received, the SFDA will determine to accept or deny the request then

respond to the applicant.

A. Accepting the Meeting Request: In case of accepting the request, notification (appendix 2) will be sent to the applicant including

date, time, place, duration and SFDA member(s) participate in the meeting.

The response will be forwarded as soon as the proposed inquiry is studied by the SFDA.

B. Denying the Meeting Request:

If the meeting request is denied, notification will be sent to the applicant including justification

for the denial.

4. Meeting Rescheduling or cancelling:

If a meeting needs to be rescheduled due to circumstances arise that necessitate the rescheduling,

the applicant should send notification to SFDA as soon as possible to allow the SFDA to prepare

a new appointment .If the meeting is cancelled by applicant or the applicant does not attend the

meeting, a subsequent request will be considered as a new meeting request.

5. Meeting Procedure: The meeting will be managed by the SFDA member (s) and will be based on the meeting request

and agenda. During the meeting the applicant has to take in to consideration that the SFDA has

the right to cancel the meeting if the applicant does not commit to the meeting request.

Before the end of the meeting, SFDA member (s) and the applicant should summarize the

important discussion points, agreements and clarifications.

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Reference:

1-The FDA Guidance for Industry Formal Meetings between the FDA and Sponsors or

Applicants, May 2009.

2-The Swiss agency for therapeutic products.

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Appendix 1:

This is a template to assist the applicant in writing the request application.

Application of Meeting Request* 1. Applicant /License holder: (include Contact person, Phone, E-mail )

2. Meeting purpose and objectives: Purpose: Objectives:

3. proposed agenda: Agenda points: Estimated time:

[***]minutes.

[***]minutes.

[***]minutes.

Note: The time should be determined for each point.

Total Estimated Time:

4. Proposed questions:

5. List of participants from the organization: Name: Title:

6. List of SFDA departments:

(Check the box) □ Executive Directorate of Licensing.

□ Executive Directorate of Inspection &Law Enforcement.

□ Executive Directorate of Product Evaluation& Standards Setting.

□ Executive Directorate of Drug & Poison Information.

□ Executive Directorate of Laboratories.

□ Executive Directorate of Pharmacovigilance & Crisis Management.

□ Executive Directorate of cosmetic products safety.

7. List of document(s)attached to support the request

8. Suggested date and time: (Three suggestions should be addressed)

Date: Time:

□ I hereby certify that the submitted information is true and accurate.

*Meeting request: filled by the applicant who requested the meeting with SFDA. * The soft copy of the template can be found under the drug sector portal in “Forms Section”.

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Appendix 2:

Meeting Response Form*

Date of Meeting:

Time:

Meeting Place:

Duration:

Accepted Agenda:

SFDA Members to Participate in The Name Title Department

Meeting:

*This form will be sent by SFDA to applicant in case the SFDA accepts the meeting request.