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. Note that PSUR is not currently required during the SFDA Registration.
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).
Enlisted below are the key objectives of a PSUR report.
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.
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.
An SFDA PSUR report should contain all the relevant and latest data related to the product. It can include:
If the day of the data lock point is 0, then the PSUR report submission days will be:
A marketing authorisation holder is required to submit a PSUR in Saudi Arabia when:
A new PSUR report of a medicinal product informs SFRA about the change in risks and benefits of an authorised product.
In addition to providing the basic PSUR information, an SFDA PSUR should also contain the following information.
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.