Insights from PBRER Assessments: A Risk-Based Approach

Pharmacovigilance is a fundamental component of public health systems, ensuring that the safety and effectiveness of medicinal products are continuously evaluated throughout their lifecycle. Periodic Benefit Risk Evaluation Reports (PBRERs) play a central role in this process by providing comprehensive assessments of cumulative safety data, identifying emerging risks, and updating the overall benefit risk profile of medicinal products. As the national regulatory authority, the Saudi Food and Drug Authority (SFDA) has strengthened its PBRER assessment framework in recent years. Between 2023 and 2025, the SFDA implemented enhanced methodologies, refined risk based prioritisation processes, and expanded regulatory actions to align with international standards and reinforce pharmacovigilance practices across the Kingdom.

Over these three years, the SFDA adopted a structured, risk-based approach to determine the level of review required for each PBRER submission. PBRER assessments were categorised using predefined risk-based prioritisation criteria. Full reviews were conducted for high-priority products such as new chemical entities or biological medicines, which involved comprehensive evaluations of cumulative benefits and safety data, clinical trial outcomes, post-marketing experience, and global regulatory actions. Summary reviews were performed for the remaining PBRER submissions and focused on key safety updates, emerging signals, global regulatory actions, and any changes in the benefit-risk profile.

When safety concerns or regulatory actions were identified, the SFDA took further actions, such as requesting label updates to safety information, conducting assessments of potential safety signals, or notifying relevant departments regarding medication errors, risk minimisation measures, or product quality issues. This structured workflow supported consistency, transparency, and timely regulatory decision-making.

From 2023 to 2025, the SFDA received and assessed 1,332 PBRERs submitted by marketing authorisation holders (MAHs). The annual outcomes reflect both the increasing volume of submissions and the expanding scope of regulatory actions taken for submissions.

The risk-based PBRER assessment method was formally adopted at the beginning of 2023. The expansion of the PBRER assessment process enhanced review capacity and the implementation of more structured pharmacovigilance activities. This resulted in more safety concerns being identified and assessed, leading to increased regulatory actions. Although the number of regulatory actions decreased slightly in 2025, it remained substantially higher than in 2023, suggesting that the strengthened PBRER assessment framework and regulatory decision-making processes established in 2023 were maintained throughout this period (Table 1).