Version 1.2

Draft

[Not for implementation and published for

comment purposes]

Date of publication 29/11/2016

2

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

Drug.comments@sfda.gov.sa

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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Figure 1. Flow chart of the submission process

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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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Figure 2. Flow chart of the approval process for advertisements

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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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Figure 3. Flow chart of the approval process for disease awareness

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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

E-mail

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

E-mail

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:

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4) Promotional Materials

A. Contact Information

(if required information is missing or incomplete)

o First name:

o Middle name:

o Family/last name:

Phone:

Mobile:

E-mail: