As part of the pharmacovigilance requirements in Saudi Arabia, the SFDA requires marketing authorisation holders (MAHs) to submit all the Individual Case Safety Reports (ICSR) to the Saudi national pharmacovigilance centre (NPC). The submission must be done by the appointed local qualified person responsible for pharmacovigilance (QPPV) in Saudi.
On this regard, we find many companies need to know the related regulations and how this process should take place. This article will outline the basic requirements for adverse drug reaction submission, who should submit the reports, and within what timelines.
Table of contents
What is ICSR?
ICSR is a reporting format for one or more suspected adverse drug reactions to a pharmaceutical product that occurs in a patient at a given time. Every MAH is responsible for collecting all reports of potential adverse reactions related to their medicinal products that come 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 has a local pharmacovigilance system in Saudi Arabia. If the MAH is a local MAH, then a Pharmacovigilance system master file (PSMF) is required. While foreign MAH companies must establish a Pharmacovigilance sub-system file (PSSF). The later 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.
The local PV system for foreign companies can be developed and maintained by a local pharmacovigilance service provider in Saudi Arabia.
Who should submit the ICSRs to SFDA?
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 now not the proper channel and no longer acknowledged.
Serious or non-serious case reporting?
The MAH must report all serious ICSRs that occurred inside or outside Saudi Arabia. However, SFDA had suspended the reporting of those that took place outside Saudi but might de-suspend that at anytime. On the other hand, reporting of non-serious cases is required for only those that occurred in Saudi Arabia.
ICSRs Reporting Timelines
The SFDA guidelines has been updates to reflect the below tramlines for reporting ICSRs:
|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 1 day)|
|Lack of Efficacy||Within 15 days|
SFDA only accepts reports 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 to them.
- Provides comments on drug-related concerns that have been reported both domestically and globally.
- It is a cost-effective approach of monitoring the safety of pharmaceutical products over the course of its lifetime.
- the most effective approach for obtaining real-world data
- Aggregate reports (PSURs) of all reported ICSRs are analysed to increases the benefit/risk profile for the drug.
Safety Report Types
In the post-authorization phase, there are two types of safety reports: those originating from unsolicited sources and those reported as solicited.
- Spontaneous reports is s communication to the SFDA or the marketing authorisation holder by a healthcare professional or a consumer that describes one or more suspected adverse reactions in a patient who was given one or more medicinal products and does not come from a study or any organized data collection systems where adverse event reporting is actively sought.
- Literature reports is a valuable source of data for monitoring the safety profile and risk-benefit balance of medicinal products, especially in the discovery of new safety signals or emergent safety concerns.
- Internet or Social Media it the responsibility of the MAH to screen the internet regularly for potential reports of suspected adverse reactions
Solicited reports are classified to be as study reports, and should undergo causality assessment to determine whether they refer to suspected adverse reactions and so 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 4 minimum requirements to make sure ICSR is valid, are:
• One or more identifiable reporter (primary source), e.g., physician, pharmacist, other healthcare professional, consumer or other non-healthcare.
• One single 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:
- Requires hospitalization or increase time of hospitalization
- Causes persistent or significant disability or incapacity
- Congenital anomaly/birth defect at any dose.
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 especially refers to reports with:
- Congenital anomalies or developmental delay.
- Fetus death and spontaneous abortion.
- Suspected adverse reactions in the neonate that are classified as serious
Suspected adverse reactions which occur in infants following exposure to a medicinal product from breast milk should be reported
- Paediatric or elderly population
- Reports of overdose, abuse, off-label use, misuse, medication error or occupational exposure