Master Pharmaceutical Products Registration in Saudi Arabia (SFDA)

About Course

Mastering Pharmaceutical Product Registration with SFDA – The Complete KSA Regulatory Roadmap

Course Description

Welcome to the most comprehensive and practical course on pharmaceutical product registration in Saudi Arabia, the largest and most influential market in the GCC region.

If you are a regulatory affairs professional, pharma manager, or industry newcomer, this course will empower you with hands-on knowledge, tools, and real-life insights to confidently navigate SFDA requirements, accelerate market entry, and maximize your ROI in one of the fastest-growing pharmaceutical markets in the Middle East.

Why This Course?

Saudi Arabia represents a multi-billion-dollar pharmaceutical market, and every major healthcare company aims to establish a presence here. But navigating SFDA regulations can be complex — that’s why this course was built “from practice, for practice.”

You’ll gain real-world expertise on classification challenges, dossier structure, submission procedures, and regulatory updates — all explained step-by-step with actual cases from industry practice.

Your Learning Journey

We’ll begin by exploring classification challenges — including the growing number of cases where SFDA classification differs from that of the country of origin. You’ll learn how to manage these scenarios efficiently and strategically.
Next, we’ll dive deep into the SFDA eSDR system, followed by a complete eCTD walkthrough — from structure and module preparation to submission and verification.
You’ll then explore two strategic registration pathways (Abridged and Verification) that can significantly reduce approval timelines, along with hands-on guidance for preparing SFDA-compliant SMPCs and PILs.
Finally, we’ll land with the newest updates — from the 2DMatrix barcode and Aggregation system to IBRCS clearance and Pharmacovigilance requirements, ensuring your readiness for end-to-end compliance.

By the End of This Course

You’ll walk away as a confident expert in pharmaceutical registration, renewal, and variations under the SFDA system — ready to lead your organization’s expansion into Saudi Arabia and achieve faster, stronger market success.

So, let’s begin this exciting journey together and start your success story in the KSA pharma market.

Introduction to the Saudi Food and Drug Authority (SFDA)
Classification Guidelines and dealing with classification mismatches
Pharmaceutical Registration Guidance and practical pathways
eCTD System (Modules 2–5) and SFDA-specific Module 1 preparation
Application Process – Step-by-step dossier submission workflow
Templates, CPP, and supporting documentation
Special registration approaches: Abridged & Verification pathways
SMPCs & PILs – mastering SFDA-approved layouts and updates
Registration Fees, Renewal, and Variations management
Tracking & Tracing with 2DMatrix and Aggregation
Custom Clearance (IBRCS) and Pharmacovigilance (PV) systems

Course Content

Module 1: Introduction
Are you ready to become a highly demanded Regulatory Affairs professional in the pharmaceutical industry? The pharmaceutical market is expanding rapidly across the GCC and globally

Introduction

05:09

Module 2: SFDA Classification Guide
In this introductory section, we will be introduced to the classification guide of the SFDA system, emphasizing on the classification mismatch, and the updated circular of the SFDA classification

Module 3: Guidelines for Pharmaceutical Registration
In this section we will be introduced to the pharmaceutical registration guidelines, and the system of the eSDR

Module 4: eCTD
In this section, we will go deeper into the actual eCTD structure, modules, checklist of each module, and how to prepare them, with a detailed explanation of module 1, the country-specific module

Module 5: eCTD M2-M5
In this section, we will explore other modules of the eCTD from module 2 to module 5, which is the core of the eCTD dossier for any pharmaceutical product

Module 6: The Application Process
In this section, we will log in to the actual SFDA system to see the actual application process and why we shifted to the eCTD. its structure, hyperlinks, benefits, and the initiative role of the ICH

Module 7: The Templates
We will dive deeper to the practice in this section and see how the templates look like, how to prepare them, their situation from legalization or notarizations to come up with the actual dossier

Module 8: CPP
This section will speak in detail about the CPP, its definition, and its conditions, what is the CEP? and its difference from the CPP

Module 9: Special Approaches for Registration
In this interesting section we will learn from practice 2 of the relatively new shortcut pathways of pharmaceuticals registration with the SFDA

Module 10: SMPCS
In this section we will learn from practice about the SMPC, and the SFDA updated format

Module 11: Registration Fees
In this section we will be explored to the registration fees and the final registration certificate, and how to maintain it by renewal and variations if any later on

Module 12: Tracking/Tracing System
In this section we will deal more with the logistics, tracking and tracing system of the pharmaceutical products, the 2DMATRIX code, its implementation, and different options of implementation

Module 13: Clearance
Here we are approaching the final part of pharmaceutical products registration with SFDA, here we are dealing with product custom clearance after we have already registered the products

Module 14: e-PIL/ eCPP/ICH
e-PIL/ eCPP/ICH

Module 15: Updated Variation Guidelines PART 1
Master Updated Variation Guidelines PART 1

Module 16: Updated variation Guidelines PART 2
Updated variation Guidelines PART 2

Module 17: Updated variation Guidelines PART 3
Updated variation Guidelines PART 3

Module 18: Updated variation Guidelines PART 4
Updated variation Guidelines PART 4

Module 19: Updated variation Guidelines PART 5
Updated variation Guidelines PART 5

Module 20: Updated variation Guidelines PART 6
Updated variation Guidelines PART 6

Module 21: Updated variation Guidelines PART 7 / Updated Tracking
Updated variation Guidelines PART 7 / Updated Tracking

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About Course

What Will You Learn?

Course Content

Module 1: Introduction Are you ready to become a highly demanded Regulatory Affairs professional in the pharmaceutical industry? The pharmaceutical market is expanding rapidly across the GCC and globally

Introduction

Module 2: SFDA Classification Guide In this introductory section, we will be introduced to the classification guide of the SFDA system, emphasizing on the classification mismatch, and the updated circular of the SFDA classification

SFDA Classification Guidelines

Module 3: Guidelines for Pharmaceutical Registration In this section we will be introduced to the pharmaceutical registration guidelines, and the system of the eSDR

Guidelines for pharmaceutical Registration

Module 4: eCTD In this section, we will go deeper into the actual eCTD structure, modules, checklist of each module, and how to prepare them, with a detailed explanation of module 1, the country-specific module

eCTD

Module 5: eCTD M2-M5 In this section, we will explore other modules of the eCTD from module 2 to module 5, which is the core of the eCTD dossier for any pharmaceutical product

eCTD M2-M5

Module 6: The Application Process In this section, we will log in to the actual SFDA system to see the actual application process and why we shifted to the eCTD. its structure, hyperlinks, benefits, and the initiative role of the ICH

The Application Process

Module 7: The Templates We will dive deeper to the practice in this section and see how the templates look like, how to prepare them, their situation from legalization or notarizations to come up with the actual dossier

The Templates

Module 8: CPP This section will speak in detail about the CPP, its definition, and its conditions, what is the CEP? and its difference from the CPP

The CPP

Module 9: Special Approaches for Registration In this interesting section we will learn from practice 2 of the relatively new shortcut pathways of pharmaceuticals registration with the SFDA

Special Approaches for Registration

Module 10: SMPCS In this section we will learn from practice about the SMPC, and the SFDA updated format

SMPCS

Module 11: Registration Fees In this section we will be explored to the registration fees and the final registration certificate, and how to maintain it by renewal and variations if any later on

Registration Fees

Module 12: Tracking/Tracing System In this section we will deal more with the logistics, tracking and tracing system of the pharmaceutical products, the 2DMATRIX code, its implementation, and different options of implementation

Tracking/Tracing System

Module 13: Clearance Here we are approaching the final part of pharmaceutical products registration with SFDA, here we are dealing with product custom clearance after we have already registered the products

Clerance

Module 14: e-PIL/ eCPP/ICH e-PIL/ eCPP/ICH

e-PIL/ eCPP/ICH

Module 15: Updated Variation Guidelines PART 1 Master Updated Variation Guidelines PART 1

Updated Variation Guidelines PART 1

Module 16: Updated variation Guidelines PART 2 Updated variation Guidelines PART 2

Updated variation Guidelines PART 2

Module 17: Updated variation Guidelines PART 3 Updated variation Guidelines PART 3

Updated variation Guidelines PART 3

Module 18: Updated variation Guidelines PART 4 Updated variation Guidelines PART 4

Updated variation Guidelines PART 4

Module 19: Updated variation Guidelines PART 5 Updated variation Guidelines PART 5

Updated variation Guidelines PART 5

Module 20: Updated variation Guidelines PART 6 Updated variation Guidelines PART 6

Updated variation Guidelines PART 6

Module 21: Updated variation Guidelines PART 7 / Updated Tracking Updated variation Guidelines PART 7 / Updated Tracking

Updated variation Guidelines PART 7 / Updated Tracking

Final

Earn a certificate