GCC Regulatory MAA & post approval requirements (Saudi Arabia & UAE) unit-5 RADC (RA)

GULF COOPERATION COUNCIL
SAUDI ARABIAAND UAE
Presented by:
Vanshika Gupta
MRA201T (RADC)
2nd sem M.Pharm (RA)
PARUL INSTITUTE OF PHARMACY
1
GULF COOPERATION COUNCIL SAUDI ARAABIA AND UAE

CONTENTS
GULF COOPERATION COUNCIL SAUDI ARABIA AND UAE 2
 GCC countries
 Drug registration
regulations of Saudi Arabia
 Medicinal
Product Registration process
(SA)
 Drug Registration
Requirement (SA)
 Post Registration
Requirements in (SA)
 Drug registration regulations
UAE
 Medicinal
Product Registration process
(UAE)
 Drug Registration
Requirement (UAE)

1. The emirate of the riyadh province
2. The emirate of the makkah province
3. The emirate of the eastern province
4. The emirate of the madinah province
5. The emirate of the al baha province
6. The emirate of the al jawf province
7. The emirate of the northern borders
province
8. The emirate of the qassim province
9. The emirate of the ha'il province
10. The emirate of the tabuk province
11. The emirate of the 'aseer province
12. The emirate of the jizan province
13. The emirate of the najran province
Saudi Arabia states Saudi Food and Drug Authority (SFDA)

Gulf Cooperation Council
(GCC)
Kuwait
Qatar
Bahrain
Oman
Cooperation Council for the Arab States of the Gulf

DRUG REGISTRATION REGULATIONS OF
THE KINGDOM OF SAUDI ARABIA
• Since 2003, The Saudi Food and Drug Authority (SFDA) is the
competent authority for registrations, maintenance, quality,
pharmacovigilance and import of medicinal products.
• SFDA is responsible for handling and licensing the manufacture, import,
export, distribution, promotion, and advertising of medicinal products.
• The SFDA is also responsible for assessing the safety, efficacy, and quality
of medicinal products, issuing marketing authorizations, and monitoring
the quality & safety of the marketed medicinal products.
• SFDA prefers the drug dossier submission in electronic format (eCTD).
• It is an independent authority from the Ministry of Health.
Drug Registration Regulations of Saudi Arabia

Agent
File application
form and
enclosures
Registration
Section
Technical
Committee for
evaluation (1)
Pending for more
information/appro
ved/not approved
Analysis
Medicinal Product Registration process (SA):

Pending for more
information/appr
oved/not
approved
Technical
Committee for
evaluation (2)
Pending for more
information
/approved/not
approved
Technical
Committee for
evaluation (3)
Acceptance or
non-acceptance
Final approval or
rejection
Medicinal Product Registration process (SA):
Conti...

The process of submitting a new Marketing Authorization Application (MAA) consists
of the following phases:
Phase 1
Step 1: Online Registration on the Drug Establishments National Registry (DENR)
The applicant register online on the DENR to get a username and password, which
enables the applicant to log in and avail all the electronic services of the drug sector.
Step 2: Marketing Authorization Application (MAA) Submission:
 The applicant shall apply through the Saudi Drug Registration (SDR) system to fill
out the application form and pay the fees.
 Upload the eCTD file to the system through the SDR system portal.
 A soft copy of the eCTD should be submitted labelled as per the SFDA guideline,
along with the hard copies of the original documents.
MAA Medicinal Product Registration (SA)

Phase 2
Step 1: Validation
The product file will be validated on technical and business bases to ensure that the
applicant fulfils the requirement.
Step 2 - Assessment, Testing and Inspection
The relevant departments will evaluate the MAA to assess quality, safety, and efficacy,
along with the onsite GMP inspection and sample analysis by the SFDA central
laboratories.
Step 3 - Pricing
The Pricing Department will review the product’s price according to the “SFDA's
pricing rules.”
Step 4 - Product Licensing
The Registration Committee will review the registration request for approval.
MAA Medicinal Product Registration (SA) Conti...

B)
Verification Process
This process will be applicable if the product has been approved and marketed by both
the European Medicines Agency (EMA) and the United States Food and Drug
Administration (USFDA).
Abridged Process
This process will be applicable if the product has been approved and marketed by either
the EMA or the US FDA.
C)
Onsite GMP inspection can be waived if the manufacturing facility is approved by the
Gulf Cooperation Council – Drug Registration

D)
For any foreign medicinal product manufacturer, it is mandatory to have an authorized
representative in Saudi Arabia for administrative support and for Regulatory
communication with the SFDA.
E)
SFDA allows the importation of non-registered products for the cases mentioned
below:
Essential drugs
Drugs for which substitutes are not available in the Saudi market

• Format: eCTD recommended.
• Module 2 to 5: according to ICH CTD format.
Module 1: Regional requirements:
• Cover letter
• Table of contents (ToC)
• Application form
• Product information: summary of product characteristics (SmPC), product
information leaflet (PIL) and labeling – all in WHO template format.
• Information on experts involved in clinical, nonclinical studies
• Environment risk assessment.
• Pharmacovigilance
• Certificate of pharmaceutical product (CoPP)
• Pricing
• Response to questions asked by SFDA (in any)
Drug registration requirements in Saudi Arabia

Module 2: Common Technical Document Summaries
• Table of Contents of Module 2-5.
• Introduction: (Section including pharmacologic class, mode of action,
and proposed clinical use of pharmaceuticals)
• Quality Overall Summary: (The whole section is required and should
reflects the information provided in Module 3)
• Non- Clinical Overall Summary:
• Clinical Overview: Biopharmaceutics, bioequivalence/bioavailability
study reports should be provided
Drug registration requirements in (SA) Conti..

Module 3: Quality
• The whole section is required and the information should be
presented
• CMC data
Module 4: Non-Clinical Study Reports
• Generally not applicable for generic products
Module 5: Clinical Study Reports
• Table of contents for Module 5
• Tabular listing of all clinical studies
• Clinical study reports
• Literature Reference
Drug registration requirements in (SA) Conti...

Certificates
• Following Certificates required:
• CoPP/ free sale certificate
• CoA
• Pork-free declaration
• Price list
Drug registration requirements in (SA) Conti...

Any changes on a registered product (includes the change in name of a marketing
authorization holder, change in name of API, deletion of manufacturing site, batch size
change, change in a manufacturing process, change in control of API, primary container
closure system, shelf life, etc) has to be submitted to the SFDA as a Variation of MAA.
Minor variations
• Type IA: Minor variations do not require prior approval before implementation. Type IA
variations should be submitted within 14 days.
• Type IB: Minor variations that must be submitted to the SFDA by MAH before
implementation, but do not require a formal approval.
The MAH must wait a period of 60 working days to ensure that the application is
deemed acceptable by the SFDA before implementing the change.
Major variations
• Type II: Major variations in which there might be a significant impact on the Quality,
Safety or Efficacy of a pharmaceutical product and require prior approval before
implementation.
Post Approval requirements in Saudi Arabia & UAE

SFDA recommends the GCC guidelines for stability study data preparation.
Stability data requirement (SA & UAE)
Active Pharmaceutical Ingredient Finished Pharmaceutical Product
Stress testing Selection of batches
Selection of batches Container closure system
Container closure system Specification
Specification Testing frequency
Testing frequency Storage conditions
Storage conditions Stability commitment
Stability commitment Evaluation
Evaluation Statements and labeling
Statements and labeling In-use stability testing
Ongoing stability studies Variations
Ongoing stability studies

Emirates of the
United Arab Emirates
Abu Dhabi
Ajman
Dubai
Fujairah
Ras Al Khaimah
Sharjah
Umm Al Quwain
Dubai Health Authority (DHA) follows the Ministry of Health and Prevention (MOHAP)

• For all pharmaceutical items, even those that are not intended to be used as
medicines, such as nutritional supplements and cosmetics, to be registered with the
Ministry of Health & Prevention (MOHAP) in the United Arab Emirates.
• The UAE government takes all necessary measures to ensure that safety standards
and procedures are followed in cases of import, export, trade, and sale of products,
which are consumed or used by the people living here.
• The approval process for drugs in Saudi Arabia is similar to many other countries.
• The drug manufacturer submit application to the SFDA, which includes data from
clinical trials, information about the manufacturing process, and other relevant data.
• The SFDA reviews application requires additional information before making
decision.
DRUG REGISTRATION REGULATIONS
UAE

Process of Pharmaceutical Product Registration UAE:
Submit the
product
registration
application
Pay the official
fee
Deliberation by
technical
committees over
the application
The application
gets forwarded to
the competent
ministerial
committee
committee
examines the
applications and
informs to
companies
Applicant to
follow up with
Pharmacological
Analysis Section

Complete the
requirements and
submit through e-
services
Technical
committee approve
registration after re-
deliberating the
submission
Ministry issues
certificates of
registration of
products if all
conditions met
product registration
certificates is valid
for five years
Process of Pharmaceutical Product Registration UAE:
Conti...

Administrative information
• Distributor of product in UAE
• Manufacturing site
• Marketing authorization holder
and power of attorney
• Manufacturer of API
• Regulatory status
• Price list
• Declaration
Product dossier
• Drug product information
• Packaging
• patient information leaflet
• Labeling
• Storage condition and shelf-life
• Composition
• Ingredients of animal origin
• Leaflet information
• Pharmacological properties
• Bioequivalence details for generic product
Drug registration requirements in UAE

1. Certificate of the product or certificate of free sales issued by the competent
authority in the country of origin
2. The certificate should contain the product brand name and formulation of the
product containing active and inactive substances.
3. Name and address of the company that has the right to marketing/ manufacturing
4. Information on the product’s shelf life and storage conditions
5. Confirmation that product is marketed in country of origin for at least two years
6. Three Samples of the product
7. Copy of internal leaflet certified by competent authorities in the country of origin
8. Certificate of Product analysis of the samples
9. Halal certificate issued by certified authorities and organizations
Requirements for Registration in UAE

References
1. Pateriya S, Janodia M, Deshpande P, Ligade V, Talole K, Kulshrestha T, et al.
Regulatory aspects of pharmaceuticals’ exports in gulf coopération council
countries. J Young Pharm [Internet]. 2011;3(2):155–62. Available from:
https://www.jyoungpharm.org/sites/default/files/10.4103-0975-
1483.80305.pdf
2. Dgra.de. [cited 2023 May 18]. Available from:
https://www.dgra.de/media/pdf/studium/masterthesis/master_el-
malahi_zohaira_2018.pdf
3. Medicinal product registration in Saudi Arabia, KSA, SFDA [Internet].
Freyrsolutions.com. [cited 2023 May 18]. Available from:
https://saudiarabia.freyrsolutions.com/medicinal-products-regulatory-support-
in-saudi-arabia

References
4. Gov.sa. [cited 2023 May 18]. Available from:
https://www.sfda.gov.sa/sites/default/files/2022-
08/The_GCC_Guidelines_0.pdf
5. Regulatory requirements for drug approval in Saudi Arabia [Internet].
Slideshare.net. [cited 2023 May 18]. Available from:
https://www.slideshare.net/Sridhars83/regulatory-requirements-for-drug-
approval-in-saudi-arabia-95472248
6. View of overview of post approval changes requirements for active
pharmaceutical ingredients in Canada, Australia and Saudi Arabia [Internet].
Jpionline.org. [cited 2023 May 18]. Available from:
https://www.jpionline.org/index.php/ijpi/article/view/1173/615

References
7. Procedures for pharmaceutical registration in UAE [Internet]. Fotis.
Fotislaw; 2022 [cited 2023 May 18]. Available from:
https://fotislaw.com/lawtify/registration-of-pharmaceuticals-in-uae/
https://www.sfda.gov.sa/sites/default/files/2021-
10/RegulatoryFramework_1.pdf
https://www.sfda.gov.sa/sites/default/files/202210/GuidanceSubmissionV5_
0.pdf

References
10. What you should know about SFDA classification and Drug registration
[Internet]. Cosmotrace.com. [cited 2023 May 19]. Available from:
https://blog.cosmotrace.com/serialization/what-you-should-know-about-sfda-
classification-and-drug-registration
11. Property JI. Register pharmaceutical products with UAE Ministry of Health?
[Internet]. Jitendra Intellectual Property. 2020 [cited 2023 May 18]. Available
from: https://jcatrademarkuae.com/how-to-register-pharmaceutical-products-
with-uae-ministry-of-health/

GCC Regulatory MAA & post approval requirements (Saudi Arabia & UAE) unit-5 RADC (RA)

Recommended

Recommended

More Related Content

What's hot

What's hot (20)

Similar to GCC Regulatory MAA & post approval requirements (Saudi Arabia & UAE) unit-5 RADC (RA)

Similar to GCC Regulatory MAA & post approval requirements (Saudi Arabia & UAE) unit-5 RADC (RA) (20)

More from Parul Institute of Pharmacy

More from Parul Institute of Pharmacy (8)

Recently uploaded

Recently uploaded (20)

GCC Regulatory MAA & post approval requirements (Saudi Arabia & UAE) unit-5 RADC (RA)