Named Patient Program (NPP): Access Pathway for Unregistered Drugs in Saudi Arabia

The Saudi Food and Drug Authority (SFDA) mandates that medicinal products must be registered before they are marketed in Saudi Arabia. However, the authority offers a route for unregistered drugs called the Named Patient Program (NPP), dedicated to certain conditions, such as life-threatening diseases or when no alternative treatment is available. This program is also available to patients who cannot participate in clinical trials. It allows the import and utilization of drugs that are not yet registered in Saudi Arabia under such circumstances.

In this article, we will discuss how the SFDA allows the import and release of these named-patient medicines.

Table of Content

• What is the Named Patient Program? 
• Who can apply for NPP? 
• Requirements
• Conditions and Responsibilities
• Regulatory Support

What is the Named Patient Program?

The SFDA has introduced a simplified process, known as the Named Patient Program (NPP), that allows healthcare facilities to import and clear certain unregistered medicines for use in specific patients or in special medical cases. It is one of the expedited pathways introduced by the SFDA.

The process does not replace the requirement for marketing authorization of medicines intended for general use in Saudi Arabia. It helps ensure that patients can receive the treatment they need as quickly as possible while maintaining the required safety and quality standards.

Who can apply for NPP?

Local pharmaceutical companies in Saudi Arabia can apply to the SFDA for case-by-case importation approval. Third-party companies, such as PharmaKnowl, also provide these services, acting as a bridge between international companies, healthcare facilities in Saudi Arabia, and the SFDA. For example, PharmaKnowl can issue the required pre-approvals, arrange shipments, clear them through customs, and deliver them to hospitals.

Requirements 

The most important requirements are:

• A local Saudi hospital must sign the need for the drug.  
• The drug must be registered with at least one of the following reference countries:

If it is not registered with any of the above authorities, then the other available option is the Special Access Program (SAP).

Conditions and Responsibilities

Healthcare facility Responsibilities

As part of the healthcare facility’s declaration, the facility confirms the accuracy of the submitted information and assumes responsibility for the safety, efficacy, and safe use of the unregistered medicine.

The medicine must be used only for the purpose for which it was requested. The healthcare facility also confirms that the product is not a controlled medicine and that no registered therapeutic alternative is available in Saudi Arabia.

The healthcare facility must also:

Importer Responsibilities

The importer must also provide a declaration confirming the accuracy of the submitted information and responsibility for the product’s safety and quality during transportation and supply to the healthcare facility.

The importer must ensure that the medicine is transported and stored in accordance with the manufacturer’s requirements, SFDA requirements, and those of other relevant government authorities. The product must be delivered directly to the beneficiary healthcare facility immediately upon the shipment’s arrival, without unnecessary delay.

Regulatory Support

We provide the support needed to secure NPP approval, receive the shipments, and deliver them to the related hospitals in Saudi Arabia. Contact us for more information.