The Saudi Food and Drug Authority (SFDA) launched the Incentive Drug List project titled as the “Incentive Initiative for the Registration of Unregistered Pharmaceutical Products”. It is to motivate the pharma industry to authorize unregistered drugs in Saudi Arabia. In this dynamic list, the authority continuously updates the drug names with specific shortage items for which it has reports of shortages. The ultimate objective is drug availability and supply security in the country. The initiative supports the objectives of Saudi Vision 2030 and provides incentives such as priority review, pricing flexibility, technical support, and reduced regulatory fees.
This article outlines the significant incentives SFDA has proposed and highlights the key advantages.
Table of contents
What Is the Drug Incentive List?
It is a project the SFDA developed to enhance the country’s drug supply security in collaboration with other parties, such as the National Unified Procurement Company (NUPCO), a semi-governmental company responsible for the Saudi drug tender. Also, in alignment with the Saudi Local Content Authority, which encourages the localization of drug products in Saudi manufacturers.
Objectives
This program has as its primary goals:
- Improving the availability and variety of medicines across the Kingdom.
- Reducing shortages of essential drugs.
- Supporting the Saudi localization Projects.
- Supporting local drug manufacturing.
- Supporting public health by maintaining timely access.
- Encouraging the entry of low-demand or economically unfeasible products.
Types of Drugs in the Incentive List
The drug incentive list contains three types of drug statuses:
- Unregistered Drugs that are in short supply in the Saudi market
- Registered, but with a single source
- Registered, but needs to be localized in Saudi manufacturers.
The authority also published, in 2025, a separate incentive list for veterinary medicines.
Types of Incentives
Eligible applicants can apply to the SFDA to express their interest in registering any of the drugs on the list and to request one or more of the incentives the authority has announced. The most attractive incentives are the expedited registration, exemption from SFDA fees, and waiver of unavailable drug dossier data.
| Incentive Type | Benefit |
|---|---|
| Access | Applications go through an expedited registration pathway, receiving priority review to shorten approval timelines. |
| Commercial | Supportive drug pricing and flexibility. |
| Technical | Waive or delay part of the drug dossier requirements, such as the stability study. |
| Financial | Reduction or exemption of the SFDA fees for the application and/or GMP inspection. |
| Consultation | Receive consultation and pre-submission discussions. |
How to Apply
International companies can approach the SFDA to apply for the incentives through their local distributors or local consulting offices. For example, we at PharmaKnowl help companies secure their incentives before they become unavailable, as they are awarded to the first applicant; then the authority removes the product or molecule from the list. Contact us for more information.
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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