Pharmaceutical Regulatory Services in Saudi Arabia
Medicines in Saudi Arabia
Saudi Arabia’s pharmaceutical sector operates under the regulatory oversight of the Saudi Food and Drug Authority (SFDA). The Authority evaluates the quality, safety and efficacy of pharmaceutical products and oversees drug registration, pricing and post-marketing safety monitoring.
Drug Registration and Evaluation
The registration process involves the assessment of product documentation and supporting evidence. Requirements vary according to the product category and application type. For human medicinal and biological products, the evaluation includes relevant quality, safety and efficacy data published by SFDA.
Pharmaceutical Establishments
Product registration and establishment licensing are distinct regulatory matters under the pharmaceutical and herbal establishments law. Companies planning pharmaceutical activities should identify the requirements relevant to their business operations alongside those applicable to the products they intend to supply.
Product Safety and Traceability
Regulatory oversight continues after a medicine enters the market. SFDA activities include post-marketing surveillance, pharmacovigilance and pharmaceutical product traceability through the RASD system.
Official Pharmaceutical Information
SFDA provides drug registration guidance, electronic application services and public lists of drug companies and licensed establishments. These resources support the review of applicable requirements and the verification of regulatory information.
Service Overview and Eligibility
Motaded provides pharmaceutical regulatory support for companies preparing to enter the Saudi market or manage existing SFDA applications. Services cover drug registration, pharmaceutical establishment licensing and import coordination, according to the company’s activities, product requirements and application status.
Who the service is for
- Pharmaceutical manufacturers and marketing authorisation holders preparing product documentation and registration applications for the Saudi market.
- Importers and distributors requiring support with establishment licensing, product registration or pharmaceutical import procedures.
- Companies entering the Saudi market seeking clarification of the regulatory requirements and documentation relevant to their planned activities.
Scope of support
- New product registration: review of available documentation and preparation of the agreed application package.
- Establishment licensing: assistance with identifying applicable requirements under the establishments law and preparing licensing documentation.
- Import coordination: review of product and shipping documentation and coordination of the agreed FASAH and customs clearance procedures.
- Existing applications: review of application records, SFDA correspondence and outstanding requests, with support for the remaining work.
The applicable requirements and scope of service are determined following an initial review. Application submission and regulatory follow-up are included where agreed and authorised.
Drug Registration, Establishment Licensing and Import Support
SFDA Drug Registration Support
Support with the preparation of pharmaceutical product registration applications for the Saudi market through SFDA.
Motaded’s scope of work
- Review the available product dossier and supporting documentation.
- Identify missing materials and inconsistencies requiring clarification.
- Prepare the agreed application package.
- Submit the application and coordinate responses to SFDA requests where submission and follow-up are included in the engagement.
Client responsibilities
Provide product and manufacturer documentation, arrange any additional technical evidence and authorise the agreed application activities.
Service outcome
A prepared application package or, where submission is included, a submitted application with a record of correspondence and outstanding requirements.
Pharmaceutical Establishment Licensing Support
Support with licensing documentation for the company’s planned pharmaceutical activities under the pharmaceutical and herbal establishments law.
Motaded’s scope of work
- Review the proposed activities and available company documentation.
- Identify the relevant SFDA licensing requirements and outstanding documents.
- Prepare the agreed licensing application.
- Coordinate submission and responses to requests where included and authorised.
Client responsibilities
Provide company and premises documentation, appoint the required responsible personnel and complete any operational or premises-related requirements.
Service outcome
A prepared licensing application or, where submission is included, a submitted application with a documented status and remaining actions.
Pharmaceutical Import Coordination
Support with the documentation and coordination required for planned pharmaceutical consignments or shipments already in Saudi Arabia, including FASAH and customs clearance where those procedures apply.
Motaded’s scope of work
- Review available product, company and shipping documentation.
- Identify outstanding information relevant to the consignment.
- Coordinate the agreed import-related work with the client and relevant service providers.
- Track requests, correspondence and outstanding actions within the agreed scope.
Client responsibilities
Provide accurate shipment information and supporting documents, coordinate with the supplier and arrange applicable payments and authorisations.
Service outcome
An organised consignment documentation package and a record of the coordinated procedures, current status and outstanding actions.
Service Scope and Client Coordination
A designated Motaded coordinator manages document requests, client communications and progress updates throughout the engagement. Before work begins, the written proposal defines the services, expected deliverables, responsibilities, service fees and payment terms, with applicable government and third-party charges identified separately. Progress updates record completed work, outstanding requirements and actions requiring the client’s attention.
Application Preparation and Follow-up
The stages below describe registration and licensing support. The applicable stages are confirmed in the written proposal; import coordination follows the requirements of the individual consignment.
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Initial Review and Scope Confirmation
Motaded reviews the product or establishment information, available documents and any existing application records. The required work, outstanding materials, responsibilities and deliverables are defined before preparation begins.
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Documentation and Application Preparation
The agreed application package is prepared using the materials supplied by the client. Missing information and inconsistencies are referred to the client or manufacturer for clarification before submission.
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Authorised Submission
Where submission is included in the engagement, Motaded submits the application through the applicable channel following client authorisation. The submission reference and available confirmation are recorded and communicated to the client.
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Regulatory Follow-up and Delivery of Records
Where follow-up is included, Motaded coordinates responses to regulatory requests and communicates application updates. At completion of the agreed work, the client receives the prepared materials, submission records and correspondence, together with any outstanding actions. Regulatory decisions remain with SFDA.
Pharmaceutical Product and Company Documentation
- Commercial Register and relevant pharmaceutical establishment licences.
- Previous SFDA application references and correspondence, if available.
- Product and manufacturer documentation: existing dossier, manufacturer certificates, composition or specification data, and current labelling.
- Shipping documents and FASAH or import records, if the request concerns a consignment.
A consultation may proceed with an incomplete file. Motaded confirms the outstanding items in writing.
Service Fees and Regulatory Charges
The quotation reflects the agreed service — drug registration, establishment licensing or import coordination — the condition of the product documentation and the status of any existing SFDA application.
Motaded service fee
- Charged for the agreed scope of work.
- Depends on the service and the readiness of the documents.
- Confirmed in the written proposal before work begins.
Government and third-party charges
- Paid separately, if they apply.
- Depend on the specific SFDA or customs procedure, including ZATCA charges where they arise.
- Known costs at the time of the proposal are listed separately.
Current government fees are confirmed on the SFDA published schedule.
Frequently Asked Questions
Are pharmaceutical services the same as medical device or cosmetics support?
Medicines, medical devices and cosmetics are processed in different SFDA systems. The landing that matches the product should be used. If classification is unclear, that should be stated on the form.
Can the SFDA government fee be confirmed in advance?
SFDA publishes the government fee for each application. Motaded confirms the service fee after reviewing the file. The Authority’s published schedule is not replaced.
Does Motaded decide whether the medicine is registered?
SFDA decides registration, licensing and any inspection. Motaded prepares the file and, where authorised, supports submission and follow-up.
Can Motaded support a consignment that has already arrived?
For consignments already in Saudi Arabia, Motaded reviews the available shipping documents, the SFDA records already held and outstanding clearance requirements. Customs clearance may also be required through customs clearance.
How is the Motaded service fee determined?
The fee depends on the product, the completeness of the file and whether the scope includes drug registration, establishment licensing or import coordination. It is confirmed in writing before work begins.