The document discusses regulatory requirements for drug registration and post-approval requirements in Saudi Arabia. It provides information on the Gulf Cooperation Council agreement between six Middle Eastern countries to harmonize regulatory standards. The Saudi Food and Drug Authority regulates drugs in Saudi Arabia, requiring electronic submissions through its eCTD format. Drugs must undergo assessment of quality, safety and efficacy to receive approval and be licensed for marketing. Post-approval, variations and renewals are regulated, and fees apply to the different application and registration types.

1. REGULATORY ASPECTS OF DRUGS & COSMETICS
(MRA 201T)
TOPIC
REGULATORY REQUIREMENTS FOR REGISTRATION OF DRUGS
AND POST APPROVAL REQUIREMENTS IN SAUDI ARABIA
(UNIT – V)
MOHAMED FAZIL M
P1821003
M PHARMACY – 2ND SEM
REGULATORY AFFAIRS
MOB: 8870884215

2. REGULATORY REQUIREMENT
Regulatory requirement is a rule, regulations,
policies, standards, law that compliance with the
government entity imposes on an organization.

3. GULF COOPERATION COUNCIL (GCC) - 1981
 The Gulf Cooperation Council
(GCC) is a political and
economic union of Arab
states bordering the Gulf.
 It was established in 1981
and its consists of 6 countries
 United Arab Emirates,
 Saudi Arabia,
 Qatar,
 Oman,
 Kuwait and
 Bahrain.

4. GCC COUNTRIES
SAUDIARABIA - Saudi Food and Drug Authority
BAHRAIN - National Health Regulatory Authority
KUWAIT – Kuwait Food and Drug Authority
QATAR – Ministry of Public Health, Pharmacy and Drug Control Department
UNITED ARAB EMIRATES - Ministry of Health (MOH)
OMAN - Directorate General of Pharmaceutical Affairs and Drug Control

5. The Saudi pharmaceutical market is one of the largest in the
Middle East and constitutes 65 percent of the GCC, which includes
Saudi Arabia, Bahrain, Qatar, Oman, Kuwait and the UAE.
The Saudi Food and Drug Authority [SFDA] is the regulatory body
of Saudi Arabia
The Saudi Food and Drug Authority (SFDA) regulates the drug
products in Saudi Arabia and enforces the drug registration
requirements.

6. Saudi Food & Drug Authority is located in Riyadh,
Saudi Arabia

8. SFDA ORGANISATION (DRUG)

9.  The submission particulars had greatly transitioned from the paper
format, through CTD, then NEES, to the current eCTD file
 SFDA prefers the drug dossier submission in electronic format (eCTD).
 The SFDA has approved more than 6177 drugs of different strength and
formulations.
 The data requirements for each application will differ, depending on the
drug submission type.
 However, all the required data should be in accordance with the CTD
structure

11.  a) In case of New Chemical Entity (NCE), Biologicals and Biosimilars ALL the
CTD Modules are required.
 b) In case of Generic Products:
 In preparing the dossier for generic products, it is acknowledged that certain
modules or sections of the CTD would generally not be applicable and should be
marked as such
 Module 1: Regional Administrative Information
 This Module is required to be submitted. It should contain documents specific to
SFDA;
 e.g., application form, proposed labelling, prescribing information

12. Module 2: Common
Technical Document
Summaries
The following sections
are required to be
submitted under
Module 2:
2.1 Table of Contents
of Module 2-5.
2.2 Introduction: This section should
begin with a general
introduction to the
pharmaceutical,
including its
pharmacologic class,
mode of action, and
proposed clinical use.
In general, the
introduction should
not exceed one page.

13. 2.3 QUALITY
OVERALL
SUMMARY:
THE WHOLE
SECTION IS
REQUIRED AND
SHOULD REFLECTS
THE INFORMATION
PROVIDED IN
MODULE 3.
2.4 NON- CLINICAL
OVERALL
SUMMARY:
2.5 CLINICAL
OVERVIEW:
2.5.2 “OVERVIEW
BIOPHARMACEUTIC
S”: THE SUMMARY
OF THE
COMPARATIVE
BIOEQUIVALENCE/BI
OAVAILABILITY
STUDY REPORTS
SHOULD BE
PROVIDED UNDER
THIS SECTION
MODULE 3:
QUALITY
3.1 TABLE OF CONTENTS
3.2 BODY OF DATA
3.2. DRUG SUBSTANCE, PRODUCT
3.3 LITERATURE REFERENCE

14. • Module 4: Non-Clinical Study Reports
• Generally not applicable for generic products
• Module 5: Clinical Study Reports
• It is anticipated that only the following relevant sections of
Module 5 will normally be
• required.
• 5.1 Table of contents for Module 5
• 5.2 Tabular listing of all clinical studies
• 5.3 Clinical study reports
• 5.4 Literature references

15. SFDA
APPLICATIONS
IN ELECTRONIC
-SDR
The following rules/conditions if met, the
submitted drug application will be accepted:
1. New Drug and Biological
2. Generic Drug that is equivalent to the
registered innovator drug (the drug shall be
registered as “New Drug” because the API is
not registered in KSA)

16. 3. Biosimilar drug only if it is manufactured locally
4. Radiopharmaceutical drug
5. Combination products (2 or more API):
6. Health product

17. STEP BY STEP
PROCEDURE:
1. Applicant shall go to the Saudi Drug
Registration system (SDR) website
(http://sdr.sfda.gov.sa/ )
2. Login to apply (each applicant should
have a user ID and a password)
3. Choose and complete the appropriate
application form:
The application form can be saved
partially as the applicant may complete
it in several steps.

18. 4. Then, the applicant has
to pay the submission fee
(through SADAD Payment
System) in order to
submit the application
form and schedule an
appointment to deliver
the hard and soft copy of
the product file:
ØSubmission fees are
mandatory in order to
proceed to the next step.
ØThe applicant can
reschedule 3 weeks
before the appointment.
An automatic reminder
will be sent 3 days
before the appointment.
ØA reference number will
be generated, and this
number should always
be used with regard to
any communication with
the SFDA.

19. 5. At the appointment, the applicant will
deliver the product file along with the
samples.
6. The Regulatory Affairs Pharmacist will
validate (Phase I) the following:
a. The application form
b. The product file (hard and soft copy)
c. The samples

21. MARKETING
AUTHORIZATION
APPLICATION
(MAA)
A. VALIDATION :
1. The product file will be validated to ensure that all
information provided are according to the
requirements and/or guidelines:
a. The completed file will proceed to the next steps in
parallel – assessment, testing and inspection.
b. If any information is missing or incorrect, the
applicant will be notified electronically. The applicant
will be given an opportunity to complete the file
within 90 days. Otherwise, the file will be rejected.

22. 2. Performance target: 10 days for all drug submission types
B. ASSESSMENT
1. The product file will be distributed by the product manager to
THREE groups: Quality, Safety and Efficacy.
2. Quality assessment will be performed by a quality group. Once
completed, a report will be forwarded to the product manager.
3. Safety assessment will be performed by a safety group. Once
completed, a report will be forwarded to the product manager.

23. 4. Efficacy assessment will be performed by an
efficacy group. Once completed, a report will be
forwarded to the product manager
5. If a clarification is required, an electronic
“Inquiry Form” will be forwarded
to the applicant through the product manager.
The response should be received
within 90 days. Otherwise, the application will
be rejected

24. PRICING
The Pricing department handles pricing requests and ensures that all
pricing requirements are met (such as the presence of a valid, updated
and authenticated Price Certificate (Form-30) and a product sample in
its final pack form). However, if more information or clarification is
required, an electronic “Inquiry Form” will be forwarded to the
applicant through the product manager. A response should be
received within 90 days.
PRODUCT LICENSING

26. VARIATION
The variation or post-marketing changes can be
classified into two categories:
A. MINOR CHANGES:
1. Type IA: minor variations that does not require prior
approval before implementation (“Do and Tell” procedure)
but require notification submitted by the marketing
authorization holder (MAH) within 60 days after
implementation.

27. 2. Type IB: minor variations that must be notified to the
SFDA by the Marketing Authorization Holder (MAH) before
implementation, but do not require a formal approval.
However, the MAH must wait a period of 120 days to
ensure that the application is deemed acceptable by the
SFDA before implementing the change (“Tell, Wait and Do”
procedure).

28. • B. MAJOR VARIATION:
• 3. Type II: major variations in which there might be a
significant impact on the Quality, Safety or Efficacy of a
medicinal product and require prior approval before
implementation

29. Total performance target (Type IA) = 60 days
Total
Total performance target (Type IB) = 120 days
Total
Total performance target (Type II) = 145 days
Total
Note: the performance target in any step will STOP if a clarification or information is
needed from the company, and will be resumed after receiving the response.
Note

32. SFDA CERTIFICATE OR SFDA APPROVAL
It is a governmental certificate issued by the Saudi Food and Drug
Authority (SFDA) after reviewing your product or company files to prove (certify)
that a product or a company has complied with the required safety, efficacy, and
quality standards set by the SFDA. I.e. it is the SFDA approval.
Companies must have the SFDA approval in the form of a certificate for
their entity and their products.
Commercial activities related to those products are also regulated by
SFDA. Therefore, they are granted certificates when they comply with the standards
and related regulations.
Manufacturers, warehouses, distributors, and consultancy companies have
to comply with the SFDA regulations, apply for approvals, get inspected, then be
granted an SFDA certificate.

34. Type SFDA Fees (SAR) SFDA eSDR fee (SAR)
Generic Drug
New drug (including
biosimilars)
40000
95000
8000
20000
Drug SFDA Fees
Drug Registration Fee
Type SFDA Fees (SAR) SFDA eSDR fee (SAR)
New Drug Renewal 30000 3000
Generic Drug
Renewal
10000 1000
Drug Renewal Fee

36. REFERENCES
 https://www.sfda.gov.sa/en/eservices?keys=&tags=2
 https://www.sfda.gov.sa/en/drug/about/sector_departments/i
m porting_clerance/Pages/Drug_Ga.aspx
 https://www.sfda.gov.sa/en/drug/eservices/Pages/default.aspx
 https://www.sfda.gov.sa/en/drug/drug_reg/Pages/default.aspx
 https://sdr.sfda.gov.sa/frmHelp.aspx
 https://www.sfda.gov.sa/ar/drug/resources/DocLib2/Regulatory
_ Framework_for_Drug_Approvals_v_5%200.pdf
 https://www.sfda.gov.sa/ar/drug/resources/DocLib2/GCC-
Human-Drugs-Subv2.1.pdf

37. THANK YOU..!!