Periodic Safety Update Report (PSUR) Submission to SFDA

In this article, we will discuss the SFDA requirements for the Periodic Safety Update Report (PSUR), also known as the Periodic Benefit-Risk Evaluation Report (PBRER). We will clarify the submission process, report content, Saudi annex, general format, and more. Note that a PSUR is not currently required during the SFDA drug registration.

What is PSUR?

A periodic safety update report (PSUR) is a report providing an overview of the risk-benefit balance of a drug product already approved for marketing. It is prepared and legally submitted to competent authorities by the marketing authorisation holders and through the appointed Saudi QPPV. The Saudi guidelines on Good Pharmacovigilance Practices (GVP) also name the PSUR as the Periodic Benefit-Risk Evaluation Report (PBRER).

Objectives of a PSUR

Enlisted below are the key objectives of a PSUR report.

• To present a complete critical analysis of the efficacy, performance, and safety of a medicinal product while considering the latest related information
• To study populations that could not be evaluated during clinical trials due to certain limitations.

The collected information is used to determine whether the product requires further study or if changes to the product information are necessary to protect the public from newly identified risks.

Format of a PSUR

According to SFDA GVP guidelines, the PSUR report in the Kingdom of Saudi Arabia (KSA) is accepted using the same format as described for PBRER in the guidance of ICH-E2C (R2). The content and timing should also be according to the ICH-E2C (R2) guidance.

Content of a PSUR

An SFDA PSUR report should contain all the relevant and latest data related to the product. It can include:

• Clinical and non-clinical studies
• Published scientific literature
• Product quality studies
• Patient support programs

PSUR Submission

If the day of the data lock point is 0, then the PSUR report submission days will be:

• Submit within 70 days: When the report covers intervals of 6 to 12 months
• Submit within 90 days: When the report covers intervals of more than 12 months.
• Submit within 90 days for an ad hoc PSUR (when no submission time is written in the request)

When to Submit a PSUR?

A marketing authorisation holder is required to submit a PSUR in Saudi Arabia when:

• A medicinal product has received SFDA approval, but its marketing authorisation holders have not submitted a PSUR yet.
• The SFDA requires authorisation holders to submit a new PSUR, which should include the latest information regarding newly identified risks and benefits of the product.

A new PSUR report of a medicinal product informs SFDA about the change in risks and benefits of an authorised product.

SFDA PSUR Requirements (Saudi Annex)

In addition to providing the basic PSUR information, an SFDA PSUR should also contain the following information.  

• The latest approved drug information in Saudi Arabia (Current labelling – SPC/PIL).
• Proposed changes to the patient information leaflet (PIL) and summaries of product characteristics (SPCs), along with all the documents that prove the effectiveness of these changes
• Proposed actions that can help reduce product risk or improve product efficacy
• Information about the direct interaction of patients in the KSA with the product
• All the reported adverse reactions of the product in the KSA
• Information about completed or ongoing clinical trials in the KSA

Submitting a PSUR is mandatory for marketing authorisation holders in the KSA. If you need more information regarding PSUR requirements, frequency and timing of submissions, and format, you can contact us at PharmaKnowl for details and consultation.