Renewal of the medicinal product’s marketing authorization (MA) is a significant regulatory milestone under the Saudi Food and Drug Authority (SFDA) that reassures the product’s continued safety, efficacy, and compliance with up-to-date quality standards. Although renewed applications follow a shorter route than new drug registrations, they must fully comply with all the most recent technical requirements and formatting rules, particularly for human, health/herbal, and veterinary products.
This article outlines the drug renewal process in the SFDA and provides category-specific submission formats in accordance with the latest guidelines.
Table of contents
Renewal Validity
As per SFDA’s requirements, all Marketing Authorization Holders (MAHs) must file for drug certificate renewal every 5 years. The renewal window opens 180 calendar days prior to the current certificate’s expiration and must be completed within this period.
Renewal Application Types
The following drug types are subject to renewal:
1. Human Medicinal Products
- New Drug
- Biologicals / Biosimilars
- Radiopharmaceutical Drug
- Generic (Multisource) Drug
2. Health / Herbal Products
- Herbal medicines and traditional remedies
- Health Products (Dietary Supplements)
3. Veterinary Products
- New Drug
- Biological Drug
- Generic (Multisource) Drug
- Herbal Veterinary Product
- Veterinary Health Product
SFDA Drug Renewal Process
SFDA applies a structured process in all categories:
- Dossier Submission: The applicant must complete the renewal form, pay the fees, and upload the dossier through the electronic Saudi Drug System (eSDR) in the following file formats:
- electronic Common Technical Document (eCTD) for human products
- Common Technical Document (CTD) for Herbal and Health Products
- Veterinary Non-eCTD electronic System (VNeeS) for veterinary products
- Business Validation: The SFDA checks for completeness and, if any information is missing or incorrect, raises an inquiry through eSDR for the requested information. The applicant must respond within the specified timeframe; otherwise, the renewal request will be rejected.
- Pricing & Product Licensing: If the file passes validation, it is reviewed by SFDA’s pricing department and sent for approval. If more information or clarification is required, an electronic inquiry will be posted via the eSDR system. The final MA renewal will be published via SDR. In case of rejection, the applicant must resubmit a new renewal request.
- Appeal Process: The applicant may appeal SFDA’s final decision.
Requirements by Product Category
Human Medicinal Products (e-CTD Format)
| Module | Requirements | Required (R)/Optional(O) |
| 1 | Cover Letter, Application Form (Renewal) | R |
| 2 | Pricing Certificate | R |
| 3 | Renewal Application Form | R |
Veterinary Products (vNeeS)
| Part | Requirements | Required (R)/Optional(O) |
|---|---|---|
| Part 1 | Cover letter | R |
| Application form | R | |
| Pharmacovigilance and System | O | |
| CPP | R | |
| Risk Management Plan (RMP), Price list | O | |
| Product formula/composition | R | |
| Summary of Product Characteristics , Labeling, Artwork | R | |
| Package insert (Arabic & English) | R | |
| Part 2 | Stability data (Active and Finished products) | R |
Herbal/Health Products (CTD)
| Module | Requirements | Required (R)/Optional(O) |
|---|---|---|
| Module 1 | Cover letter | R |
| Comprehensive table of content | R | |
| Application form | R | |
| Certificates -CPP/Free sales & Certificate of Suitability for TSE | R | |
| Pricing (if applicable) | R | |
| Summary of Product Characteristics (if applicable) | O | |
| Patient Information Leaflet (if applicable) (Arabic and English leaflets) | R | |
| Labeling, Sample and Artwork | R | |
| Module 3 | 3.2.S Control of Drug Substance: Manufacturer, Specifications | R |
| 3.2.P Control of Drug Product: Description and Composition of the Drug Product, Specifications and Stability | R |
SFDA Renewal Rejection Causes
The renewal request shall be rejected in the following cases:
- No response from applicant within the defined working timeframe.
- Unacceptable/incomplete clarification responses.
- If the applicant exceeds the maximum number of submissions allowed.
SFDA Renewal Timelines
| Renewal Process | Timelines |
| Business Validation | 30 working days |
| Pricing | 60 working days |
| Product Licencing | 60 working days |
| Appeal | 60 working days |
Need expert help with SFDA renewals?
PharmaKnowl supports complete SFDA drug renewal by managing dossier updates, renewal SDR submissions, timeline tracking, and regulatory formatting across all product categories.
Contact us to complete your renewal process.
About the Author
Contributed by the PharmaKnowl regulatory affairs team, based in Riyadh. Written and reviewed by our SFDA-experienced consultants.
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