In this article, we will talk about the SFDA requirements for PSUR report submission, content, format, and more. Starting with an introduction and definitions of PSUR for those unfamiliar with this Pharmacovigilance term.
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 guidelines for PSUR were revised in 2012, and a new report format was introduced, due to which the report name PSUR was changed to PBRER (Periodic Benefit-Risk Evaluation Report).
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 you could not evaluate during clinical trials due to certain limitations.
The collected information is used to decide whether the product needs to be studied more or you should bring changes to product information 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
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 12 plus 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.
- SFDA demands that the authorisation holders submit a new PSUR consisting of the latest information regarding newly found risks and benefits of the product.
A new PSUR report of a medicinal product informs SFRA about the change in risks and benefits of an authorised product.
SFDA PSUR Requirements
In addition to providing the basic PSUR information, an SFDA PSUR should also contain the following information.
- The latest information about the product that is approved in the KSA
- 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 reach out to PharmaKnowl for detail and consultation.