Version 1.2
Draft
[Not for implementation and published for
comment purposes]
Date of publication 29/11/2016
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Regulatory Framework for Drug
Promotion and Advertising
Version 1.2
Drug Sector
Saudi Food & Drug Authority
Kingdom of Saudi Arabia
Please review and send your comments and suggestions within
90 days of publication to
Please visit the SFDA’s website at
http://www.sfda.gov.sa/en/drug/drug_reg/Pages/default.aspx
for the latest updates.
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Drug Sector
Vision and Mission
Vision
To be the leading regional drug regulatory authority for pharmaceuticals and cosmetic products,
with professional excellence and services that contribute to the protection and advancement of
public health in the Kingdom of Saudi Arabia.
الرؤية
قلميياً يف الرقابة عىل ال دوية ومس تحرضات التجميل، ويقدم خدماته مبهنية ممتزية تسهم يف حامية أ ن يكون قطاع ادلواء رائداً ا
وتعزيز الصحة يف اململكة العربية السعودية.
Mission
To protect public health by ensuring the safety, quality, efficacy, and accessibility of human and
veterinary drugs and biological products as well as the safety of cosmetics through
administration of a national regulatory system, which is consistent with international best
practices. We also aim to provide accurate and scientific-based information to both the public
and health-care professionals.
الرساةل
حامية الصحة العامة من خالل ضامن أ مان وجودة وفعالية وتوفر ال دوية البرشية والبيطرية واملنتجات احليوية وسالمة مواد
س علمية سالتجميل عرب تطبيق نظام وطين للرقابة متوافق مع أ فضل املامرسات ادلولية وتقدمي املعلومات ادلوائية املبنية عىل أ
.للعامة واملهنيني الصحيني
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Document Control
Version Author Date Comments
1.0 Drug Sector 6/3/2016 Initial draft
1.1 Drug Sector 13/3/2016 Internal review
1.2 Drug Sector 29/11/2016 Draft for public review
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Table of Contents 1) Introduction ......................................................................................................................... 6
2) Scope .................................................................................................................................. 6
3) Submission Process ............................................................................................................. 7
4) Types of Applications .......................................................................................................... 9
A. Approval Process for Advertisements .................................................................................. 9
1) Validation............................................................................................................................ 9
2) Committee ........................................................................................................................... 9
3) Decision .............................................................................................................................. 9
B. Approval Process for Disease Awareness ........................................................................... 11
1) Validation.......................................................................................................................... 11
2) Evaluation ......................................................................................................................... 11
3) Committee ......................................................................................................................... 11
4) Decision ............................................................................................................................ 11
C. Approval Process for Scientific Lectures ........................................................................... 13
1) Validation.......................................................................................................................... 13
2) Decision ............................................................................................................................ 13
D. Approval Process for Promotional Materials ...................................................................... 14
1) Validation.......................................................................................................................... 14
2) Decision ............................................................................................................................ 14
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1) Introduction
The Drug Sector of the Saudi Food & Drug Authority (SFDA) has developed this
document, “Regulatory Framework for Drug Promotion and Advertising,” to assist
stakeholders with submitting various types of applications, including for pharmaceutical
advertisements, disease awareness campaigns, scientific lectures, and promotional
materials. This document is an administrative instrument that outlines the requirements of
various types of applications to be completed and submitted to the SFDA.
It is important to note that the SFDA reserves the right to request information, materials,
or defined conditions not specifically described in this document to allow the
administration to adequately assess the references information of various request forms
(applications). The SFDA is committed to ensuring that such requests are justifiable and
that decisions are clearly documented.
This document should be read in conjunction with the other relevant and applicable
guidance documents. A copy of this document can be found in the guidelines section of
SFDA website.
2) Scope
The document applies to the following:
Scientific lectures
Drug advertisements
Disease awareness campaigns
Promotional materials
All submitted information and material will be screened to ensure completeness. The same
management principles will be applied consistently to all application types.
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3) Submission Process
The process of submitting an advertisement application (AD), a disease awareness (DA)
campaign, a scientific lecture (SL), or promotional materials request to the SFDA includes
the following:
1. Submitting the application form online
2. Delivering drug samples in person (for advertisement application (AD) forms
only).
Note: All days mentioned throughout this document are working days (subject to
change).
Step-by-Step Procedure (Figure 1)
1. Go to the drug promotional system (DPS) website (to be launched soon).
2. Log in to apply. Each applicant should have a user ID and a password similar to
SDR user.
3. Choose and complete the appropriate application form. The application form can
be saved partially as the applicant may complete it in several steps.
4. Finally, pay the submission fee through the SADAD Payment System in order to
process the review of application form and advertisement material + drug sample
(for ADs only). A reference number will be generated, and this number should be
used for all communications with the SFDA.
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4) Types of Applications
A. Approval Process for Advertisements
Advertisement applications are subject to the following processes:
1) Validation
a. The reviewer will validate the request to ensure that all information
provided is in accord with the requirements and/or guidelines.
b. The reviewer will validate the drug samples.
c. The completed request will proceed to prepare report by reviewer.
d. If the drug sample or any information is missing or incorrect, the applicant
will be notified electronically. The applicant will be given an opportunity
to complete the request within 60 days. Otherwise, the application will be
rejected. If the prepared report is completed, the request will proceed to the
committee.
Performance target: five days.
2) Committee
Members of the committee will make a decision within 20 days.
3) Decision
If the application is accepted:
a) Approval with commitment will be issued.
b) The applicant will be notified electronically to complete the requirements.
The applicant will be given an opportunity to complete the requirements
within one year. Otherwise, the application will be rejected.
c) If the requirements are completed, the request will proceed to the final
approval stage, after which a letter will be issued.
If it is rejected, the applicant will be notified.
Performance target: five days.
The applicant will have an opportunity to object to the commitment within 60 days.
Otherwise, the objection will not be accepted.
Total performance target = 30 days
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B. Approval Process for Disease Awareness
Disease awareness applications are subject to the following processes:
1) Validation
a. The reviewer will validate the request to ensure that all information
provided is in accord with the requirements and/or guidelines:
b. If any information is missing or incorrect, the applicant will be notified
electronically. The applicant will be given an opportunity to complete the
request within 60 days. Otherwise, the application will be rejected.
Performance target: five days.
2) Evaluation
a. A staff member will evaluate the request.
b. If clarification is required, an electronic inquiry form will be forwarded to
the applicant. The SFDA should receive a response within 60 days.
Otherwise, the application will be rejected
c. The completed request will proceed to report preparation.
Performance target: five days.
3) Committee
Members of the committee will make a decision within 20 days.
4) Decision
If the application is accepted:
a) Approval with commitment will be issued.
b) The applicant will be notified electronically to complete the
requirements. The applicant will be given an opportunity to complete
the requirements within one year. Otherwise, the application will be
rejected.
c) If the requirements are completed, the request will proceed to the final
approval stage, after which a letter will be issued.
If it is rejected, the applicant will be notified.
Performance target: five days.
The applicant will have an opportunity to object to the commitment within 60
days. Otherwise, the objection will not be accepted.
Total performance target = 35 days
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C. Approval Process for Scientific Lectures
Scientific lecture applications are subject to the following processes:
1) Validation
a. The reviewer will validate the request to ensure that all information
provided is in accord with the requirements and/or guidelines.
b. If any information is missing or incorrect, the applicant will be notified
electronically. The applicant will be given an opportunity to complete the
request within five days. Otherwise, the request will be rejected.
Performance target: seven days.
2) Decision
If accepted, the request will proceed to the final approval stage, after
which a letter will be issued.
If the request is rejected, the applicant will be notified.
Performance target: five days.
Total performance target = 12 days
Figure 4. Flow chart of the approval process for scientific lectures
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D. Approval Process for Promotional Materials
Promotional materials applications are subject to the following processes:
1) Validation
a) The reviewer will validate the request to ensure that all information
provided is in accord with the requirements and/or guidelines
b) If any information is missing or incorrect, the applicant will be notified
electronically. The applicant will be given an opportunity to complete
the request within five days. Otherwise, the request will be rejected.
Performance target: seven days.
2) Decision
If accepted, the request will proceed to the final approval stage, after
which a letter will be issued.
If the request is rejected, the applicant will be notified.
Performance target: five days.
Total performance target = 12 days
Figure 5. Flow chart of the approval process for promotional materials
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Applications for Pharmaceutical Advertisements, Disease
Awareness Campaigns, Scientific Lectures, and Promotional
Materials
1) Advertisements
A. Product Information
Trade name:*
Generic name:*
Scientific name:
Manufacturer name:
Product agent:
Product marketer:
Dosage form:
Strength/unit:
Route of administration:
Product registration no.:
Executing agency (if different from company that made request):
Type of product:
OTC
Prescription
Herbal
Health
Package size(s):
Package
Size Volume
Unit of
Volume
*This information will be extracted from the SFDA’s registered drug list.
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B. Shape (Structure, Nature) of Advertising*
Text
Audio
Video*
Mobile phone messages
Internet
Advertising posters
Other (specify):
*Select no more than three options.
Target group: males females children health practitioners
C. Contact Information
(if required information is missing or incomplete)
o First name:
o Middle name:
o Family/last name:
Phone:
Mobile:
E-mail:
*Add attachments.
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2) Disease Awareness and Health Education Campaigns
A. Disease Awareness and Health Education Campaign Information
Title of campaign:
Subject of campaign:
Campaign language: Arabic English
B. Shape (Structure, Nature) of Campaign*
Text
Audio
Video*
Mobile phone messages
Advertising posters
Internet
*Select no more than three options.
Target group: males females children health practitioners
C. Contact Information
(if required information is missing or incomplete)
o First name:
o Middle name:
o Family/last name:
Phone:
Mobile:
E-mail:
*Add attachments.
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3) Scientific Lectures
A. Scientific Lecture Information
Lecture title:
Lecture summary:
Company name:
Date of event:
City:
Location of event:
Time of event:
B. Health-Care Professionals Requirements
B.1 Requirements of Speaker
Name of speaker:
Copy of speaker’s Saudi Commission for Health Specialties registration
card (if speaker works in Saudi Arabia):*
Copies of speaker’s Saudi Commission for Health Specialties registration
card equivalent and passport (if speaker works outside of Saudi Arabia):*
CV:*
B.2 Requirements of Chairperson
Name of chairperson*:
Copy of Saudi Commission for Health Specialties registration card:*
Copy of Saudi ID card OR Saudi Passport:*
CV:*
*Add attachments
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C. Contact Information
(if required information is missing or incomplete)
o First name:
o Middle name:
o Family/last name:
Phone:
Mobile:
E-mail: