Under Saudi Arabia’s pharmacovigilance requirements, marketing authorization holders (MAHs) must submit all local Individual Case Safety Reports (ICSRs) to the Saudi Food and Drug Authority (SFDA). The appointed local Saudi qualified person responsible for pharmacovigilance (QPPV) must submit the reports directly to the SFDA.
In this regard, many companies need to understand the relevant regulations and how this process works. This article outlines the basic requirements for adverse drug reaction submissions, who should submit the reports, and the timelines involved.
Table of contents
What is ICSR?
ICSR is a reporting format for one or more suspected adverse drug reactions (ADRs) 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, enabling the collection of adequate data for the scientific assessment of such reports. Reports obtained for clinical evaluation must be authentic, readable, accurate, consistent, verified, and complete. In accordance with applicable SFDA data protection regulations, all notifications containing pharmacovigilance data shall be documented and archived.
MAH Responsibilities
The MAH company must have a pharmacovigilance system in Saudi Arabia. The Saudi MAH must have a comprehensive system known as a Pharmacovigilance System Master File (PSMF). In contrast, foreign MAH companies operating in the Saudi market only require a local PSMF, known as a Pharmacovigilance Sub-System File (PSSF). The PV system must collect and record all ICSR reports, including those originating from literature monitoring, using 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.
Who should submit the ICSRs to SFDA?
The appointed local QPPV should submit the ICSR to the SFDA through the reporting platform. The SFDA previously accepted ICSR reporting via email; however, this is no longer the proper channel and is no longer acknowledged.
Serious or non-serious case reporting?
The MAH must report all serious and non-serious ICSRs that originate within Saudi Arabia. The authority previously required submission of serious cases originating outside Saudi Arabia, but it has suspended this requirement.
ICSR Reporting Timelines
The SFDA guidelines have been updated to reflect the following timelines 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 |
ICSR Format
SFDA accepts reports only in XML format, according to ICH standards.
Benefits of ADR Reporting
- Reduces drug-related issues
- Increases patient trust in professional practice by improving the quality of treatment provided.
- Provides comments on drug-related concerns that have been reported both domestically and globally.
- It is a cost-effective approach to monitoring the safety of pharmaceutical products throughout their lifetime.
- The most effective approach for obtaining real-world data
- Aggregate reports (PSURs) of all reported ICSRs are analyzed to enhance the benefit-risk profile for the drug.
Safety Report Types
In the post-authorization phase, two types of safety reports exist: those originating from unsolicited sources and those reported as solicited.
Unsolicited reports
- Spontaneous reports are communications to the SFDA or the marketing authorization holder by a healthcare professional or a consumer that describe one or more suspected adverse reactions in a patient who was given one or more medicinal products. They do not come from a study or any organized data collection systems where adverse event reporting is actively sought.
- Literature reports are a valuable data source for monitoring the safety profile and risk-benefit balance of medicinal products, especially in identifying new safety signals or emergent safety concerns.
- The Internet or Social Media is the responsibility of the MAH to screen regularly for potential reports of suspected adverse reactions.
Solicited reports
Solicited reports are classified as study reports and should undergo causality assessment to determine whether they refer to suspected adverse reactions and fulfill the reporting standards.
ICSR Validation
According to the ICH-E2D guideline, all reports of suspected adverse reactions should be evaluated to ensure that they meet the minimal reporting requirements before being reported to the SFDA.
The four minimum requirements to ensure an 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 substances/medicinal products
- One or more suspected adverse reactions
Seriousness
A serious adverse reaction is defined as any untoward medical occurrence that causes:
- Death.
- Life-threatening.
- Requires hospitalization or increases the length of hospitalization.
- Causes persistent or significant disability or incapacity.
- Congenital anomaly/birth defect at any dose.
Special Situations
Pregnancy
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:
- Congenital anomalies or developmental delay.
- Fetal death and spontaneous abortion.
- Suspected adverse reactions in the neonate that are classified as serious
Breastfeeding
Suspected adverse reactions that occur in infants following exposure to a medicinal product from breast milk should be reported.
Pediatric or elderly population
Reports of overdose, abuse, off-label use, misuse, medication error, or occupational exposure
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