As part of the pharmacovigilance requirements in Saudi Arabia, the SFDA mandates marketing authorisation holders (MAHs) to submit all Individual Case Safety Reports (ICSR) to the Saudi National Pharmacovigilance Centre (NPC)—the appointed local Saudi qualified person responsible for pharmacovigilance (QPPV) has to perform the submission directly to the SFDA.
In this regard, many companies need to know the related regulations and how this process should occur. This article will outline the basic requirements for adverse drug reaction submission, who should submit the reports, and within what timelines.
ICSR is a reporting format for one or more suspected adverse drug reactions to a pharmaceutical product that occur in a patient at a given time. Every MAH is responsible for collecting all reports of potential adverse reactions related to their medicinal products from solicited or unsolicited sources. A pharmacovigilance system should be designed for this purpose, allowing for adequate data collection for the scientific assessment of such reports. The obtained reports for clinical evaluation are authentic, readable, accurate, consistent, verified, and completed. Following the applicable SFDA regulation of data protection, all notifications containing pharmacovigilance data shall be documented and archived.
The MAH company must have a local pharmacovigilance system in Saudi Arabia. If the MAH is local, then a Pharmacovigilance system master file (PSMF) is required. In contrast, foreign MAH companies must establish a Pharmacovigilance sub-system file (PSSF). The latter is similar to the PSMF structure but reflects the local company system details. The PV system must explain the process of collection and recording of all ICSR reports with a mechanism that enables traceability and proper follow-up reports.
A local pharmacovigilance service provider in Saudi Arabia can develop and maintain the local PV system for foreign companies.
The appointed qualified person for pharmacovigilance (QPPV) is the one who should submit the ICSR to the SFDA. This QPPV should be already registered in SFDA and have access to the reporting platform. The SFDA used to accept reporting of ICSRs by email; however, it is no longer the proper channel and is no longer acknowledged.
The MAH must report all serious ICSRs inside or outside Saudi Arabia. However, SFDA had suspended the reporting of those outside Saudi Arabia but might de-suspend that at any time. On the other hand, reporting non-serious cases is required only for those that happened in Saudi Arabia.
The SFDA guidelines have been updated to reflect the below tramlines for reporting ICSRs:
| Report Type | Duration |
| Unexpected – Serious | Within 15 days |
| Unexpected – Non-Serious | Within 15 days |
| Expected – Serious | Within 15 days |
| Expected – Non-Serious | Within 90 days |
| Product Quality | Immediately (within one day) |
| Lack of Efficacy | Within 15 days |
SFDA only accepts reports in XML format according to ICH standards.
In the post-authorisation phase, there are two types of safety reports: those originating from unsolicited sources and those reported as solicited.
Solicited reports are classified as study reports and should undergo causality assessment to determine whether they refer to suspected adverse reactions and fulfil the reporting standards.
According to the ICH-E2D guideline, before reporting suspected adverse reactions to the SFDA, all reports of suspected adverse reactions should be evaluated to ensure that they meet the minimal reporting requirements.
The four minimum requirements to make sure ICSR is valid are:
• One or more identifiable reporters (primary source), e.g., physician, pharmacist, healthcare professional, consumer or non-healthcare.
• One identifiable patient, e.g., patient initials, patient identification number, date of birth, age, age group or gender.
• One or more suspected substance/medicinal product
• One or more suspected adverse reaction
A serious adverse reaction is defined as any untoward medical occurrence that causes:
ICSRs of an embryo being exposed to medical products should be followed up to gather information on the pregnancy’s outcome and the child’s development after birth. Individual cases of an unexpected result linked to a pharmaceutical product after exposure during pregnancy are classified as severe reports and must be documented according to the standards. This mainly refers to reports with:
Suspected adverse reactions which occur in infants following exposure to a medicinal product from breast milk should be reported.
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