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Published by regulatory affairs team in PharmaKnowl, Riyadh office.
Renewal of the drug marketing authorization (MA) is a significant regulatory milestone under the 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, herbal, and veterinary products.
This article outlines the process of drug renewal with the SFDA and provides category-specific submission formats following the latest guidelines.
Table of contents
Renewal Validity
Under SFDA, 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 (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 eCTD file.
- Business Validation: The SFDA checks for completeness and raises a clarification request through SDR if any information is missing. The applicant must respond within 30 working days; otherwise, the renewal will be rejected.
- Pricing & Product Licensing: If the file gets validated, it is reviewed by SFDA’s pricing department and sent for approval. The final MA Renewal gets published via SDR.
Requirements by Product Category
Human Medicinal Products (e-CTD Format)
| Module | Requirements | Required (R)/Optional(O) |
| 1 | Cover Letter, Application Form (Renewal) | R |
| Pricing & declaration | R |
Veterinary Products (vNees)
| Part | Requirements | Required (R)/Optional(O) |
|---|---|---|
| Part 1 | Cover letter | R |
| Application form | R | |
| Pharmacovigilance and System | O | |
| CPP | R | |
| RMP, Price list | O | |
| Product formula / composition | R | |
| SPC, 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 |
| Application form | R | |
| Certificates -CPP & Certificate of Suitability for TSE | R | |
| Pricing (if applicable) | R | |
| SPC (if applicable) | O | |
| PIL (if applicable) (Arabic and English leaflets) | R | |
| Labeling 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 Risks
The renewal request shall be rejected in the following cases:
- No response from applicant within the defined working days:
- 30 working days during Business Validation
- 60 working days during Pricing Review
- Unacceptable/incomplete clarification responses.
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 carry out your renewal process.
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