Pharmaceutical Product Registration in Saudi Arabia - Overview
The Saudi Food and Drug Authority (SFDA) is the key drug Regulatory authority in Saudi Arabia and oversees the Pharmaceutical Regulatory Affairs in Saudi Arabia. The SFDA is responsible for the pharmaceutical product registration in Saudi Arabia, as well as the manufacture, import, export, distribution, promotion, and advertising of medicinal products. The SFDA also assesses the safety, efficacy, and quality of medicinal products, issues marketing authorizations, and monitors the quality & safety of the marketed medicinal products.
The SFDA requires that all medicinal products marketed in Saudi Arabia be registered with the SFDA. The Saudi Arabia Drug registration and approval process is a complex and time-consuming process, but it is essential for any company that wants to market its products in Saudi Arabia meet SFDA regulations. Companies must comply with the SFDA drug registration regulation and Saudi Food and Drug Authority regulations and guidelines to successfully register their products.
The SFDA registers only medicinal products that meet its strict safety, efficacy, and quality standards. Additionally, the SFDA mandates that all medicinal products must be manufactured in facilities compliant with Good Manufacturing Practices (GMP).
Drug Approval Process in Saudi Arabia may take several months, or even years, to complete. It is important to work with a qualified pharmaceutical consultant to ensure the product meets SFDA registration requirements and the process is completed smoothly and efficiently.
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Medicinal Product Classification in Saudi Arabia
In the Kingdom of Saudi Arabia (KSA), medicinal products are classified into the following categories:
- New Drug
- New Chemical Entity
- Generic Drugs
- Biological Drugs
Saudi Arabia Drug Registration and Approval Process
Below is a brief description of the SFDA drug registration requirements process:
A) Market Authorization
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 should register online on the DENR to get a username and password, which enables the applicant to log in and avail of 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 in three (03) CDs labeled as per the SFDA guideline, along with the hard copies of the original documents (like the cover letter, the Certificate of a Pharmaceutical Product (CPP), and the application form).
Phase 2
Step 1: Validation
The product file will be validated on technical and business bases to ensure that the applicant fulfills 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.
B) Verification and Abridged Procedure
Verification Process
This process will be applicable if the product has been approved and marketed by both the United States Food and Drug Administration (USFDA) and the European Medicines Agency (EMA).
Abridged Process
This process will be applicable if the product has been approved and marketed by either the USFDA or the EMA.
C) Waiver of Onsite GMP Inspection
Onsite GMP inspection can be waived if the manufacturing facility is approved by the Gulf Cooperation Council – Drug Registration.
D) Importance of Local Entity for a Foreign Manufacturer
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) Importation of Non-Registered Product
SFDA allows the importation of non-registered products for the cases mentioned below:
- New essential drugs.
- Drugs for which substitutes are not available in the Saudi market.
However, before importation, the local agent must obtain an import permit for each shipment from the Agency.
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Product Maintenance & Compliance
|
Sr. No |
Application |
Validity |
|
01 |
Validity for Registration Certificate |
Five (05) years from the date of registration |
|
02 |
Renewal of Registration Certificate |
The renewal application should be submitted six (06) months before the expiration of the existing registration certificate |
|
03 |
Post-approval Changes (Variations) |
Any change of registered medicine should be sent to the SFDA with relevant documents on a case-by-case basis |
Pharmaceutical Product Registration in Saudi Arabia - Freyr Expertise
Freyr is a proven expert in Saudi pharma Regulatory services and provided full support for pharmaceutical Regulatory Affairs in Saudi Arabia. Our services include:
Freyr is a global Regulatory consulting firm with a proven track record of success in Saudi Arabia’s drug registration and approval. The company possesses a deep understanding of the SFDA's regulations and requirements and has a team of experienced consultants who can help companies navigate the complex Saudi Arabia drug registration and approval process.
Freyr is a trusted partner for companies seeking to enter the Saudi Arabia market and has expertise and experience to help companies overcome the challenges of Saudi Arabia’s drug registration and approval.
Freyr offerings include:
- End-to-end Pharmaceutical Product Registration in Saudi Arabia.
- Authorized Local Agent Support.
- GMP Support and Pharma Product Regulatory Support in Saudi Arabia.
- Regulatory Affairs Consulting.
- Dossier Gap Analysis as per the SFDA Registration Requirements.
- Preparation of Gap Analysis Report and Remediation Plan.
- Pharmaceutical Dossier Preparation and Submission to the SFDA.
- Query Support Management Until Approval.
- Pharmaceutical Life Cycle Management Support.
- Ad-hoc Regulatory Affairs Consultation.
Do you want to accelerate your SFDA product registration and navigate the Drug Approval Process in Saudi Arabia? Contact Freyr today to streamline your SFDA registration process and pave the way for compliance and success!