VII.A. INTRODUCTION
PSUR/PBRERs are pharmacovigilance documents intended to provide an evaluation of the benefit-risk balance of a medicinal product for submission by MAHs at defined time points during the post-authorization phase.
The format of PSUR/PBRERs shall follow the structure described in the annex 1. This Module provides guidance on the preparation, submission and assessment of PSUR/PBRERs.
The scope, objectives, format and content of the PSUR/PBRER are described in VII.B.. The required format and content of PSUR/PBRERs in the KSA are based on those for the Periodic Benefit Risk Evaluation Report (PBRER) described in the ICH-E2C(R2) guideline (see Annex IV ICH-E2C(R2)). The PBRER replaces the PSUR/PBRER format previously described in the ICH-E2C(R1). In the KSA, the report shall be described and named as PSUR/PBRER.
Further details and guidance for the submission of PSUR/PBRERs in the KSA, including the frequency of submission are provided in VII.C.
MAHs should submit PSUR/PBRERs to the SFDA according to the following timelines:
• within 70 calendar days of the data lock point for PSUR/PBRERs covering intervals up to 12 months (including intervals of exactly 12 months); and
• within 90 calendar days of the data lock point for PSUR/PBRERs covering intervals in excess of 12 months;
• the timeline for the submission of ad hoc PSUR/PBRERs requested by the SFDA will normally be specified in the request, otherwise the ad hoc PSUR/PBRERs should be submitted within 90 calendar days of the data lock point.
It should be noted that detailed listings of individual cases shall not be included systematically. The PSUR/PBRER should focus on summary information, scientific safety assessment and integrated benefit-risk evaluation.
The obligations imposed in respect of PSUR/PBRERs should be proportionate to the risks posed by medicinal products. PSUR/PBRER reporting should therefore be linked to the RMPs (RMPs) of a medicinal product (see Module V). The “modular approach” of the PSUR/PBRER described in VII.B.5. aims to minimize duplication and improve efficiency during the preparation and review of PSUR/PBRERs along with other regulatory documents such as the development safety update report (DSUR) or the safety specification in the RMP, by enabling the common content of particular sections where appropriate to be utilized interchangeably across different PSUR/PBRERs, DSURs and RMPs.
The new legislation also waives the obligation to submit PSUR/PBRERs routinely for generic medicinal products, well-established use medicinal products, homeopathic medicinal products and traditional herbal medicinal products. For such products, PSUR/PBRERs shall be submitted where there is a condition in the marketing authorization or when requested by the SFDA on the basis of concerns relating to pharmacovigilance data or due to the lack of PSUR/PBRERs for an active substance after its authorization. However, if the generic product is the first registered in Saudi Arabia, the MAH should submit the PSUR/PBRER to SFDA according to timelines provided in VII.C.
SFDA shall assess PSUR/PBRERs to determine whether there are new risks or whether risks have changed or whether there are changes to the benefit-risk balance of medicinal products.
As part of the assessment, it should be considered whether further investigations need to be carried out and whether any action concerning the marketing authorizations of products containing the same active substance or the same combination of active substances, and their product information is necessary.
This GVP Module VII may be reviewed and updated following further development and finalization of the ICH-E2C(R2) guideline on PBRER.