Related Experiment Video
Updated: Mar 5, 2026
04:43
COVID-19 Seroprevalence Test for IgG Antibody Levels Among Healthy Donors Across Different Pandemic Phases in Jeddah
Published on: June 24, 2025
586
Pharmacovigilance system in Saudi Arabia
Thamir M Alshammari1, Mohammed Alshakka2, Hisham Aljadhey3
1College of Pharmacy, University of Hail, Hail, Saudi Arabia; Medication Safety Research Chair, King Saud University, Riyadh, Saudi Arabia.
Summary
Pharmacovigilance in Saudi Arabia involves multiple stakeholders for safe drug use. Greater attention is needed from marketing authorization holders and healthcare professionals to strengthen these vital drug safety activities.
Area of Science:
- Pharmacovigilance and Drug Safety
- Public Health Policy
- Pharmaceutical Regulation
Background:
- Pharmacovigilance is crucial for ensuring medication safety.
- While established in developed countries, pharmacovigilance is a relatively new concept in Saudi Arabia.
- Several stakeholders, including the Saudi Food and Drug Authority (SFDA), health institutions, marketing authorization holders, and healthcare professionals, participate in pharmacovigilance.
Purpose of the Study:
- To review the current state of pharmacovigilance in Saudi Arabia.
- To outline the pharmacovigilance activities undertaken by various stakeholders in the region.
Main Methods:
- This study is a review of existing literature and data on pharmacovigilance in Saudi Arabia.
- It synthesizes information regarding the roles and involvement of different stakeholders.
Main Results:
- Pharmacovigilance activities in Saudi Arabia are a collaborative effort involving multiple entities.
- The practice of pharmacovigilance requires enhanced engagement, particularly from marketing authorization holders and healthcare professionals.
- Despite progress, the system's effectiveness is contingent on broader participation and adherence.
Conclusions:
- Strengthening pharmacovigilance in Saudi Arabia necessitates increased commitment from marketing authorization holders and healthcare professionals.
- A collective effort is essential for promoting the safe and effective use of medicines within the population.
- Further development and attention are required to fully establish robust drug safety monitoring in the Kingdom.
More Related Videos
Related Concept Videos
01:19Pharmacovigilance
1.9K
Post-marketing surveillance is a critical component of pharmaceutical regulation, often uncovering unanticipated adverse drug reactions (ADRs) once a drug is widely used over an extended period.
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
1.9K
01:25Drug Regulation
3.2K
Drug regulation encompasses the management of drug usage by evaluating its safety and efficacy through assessments conducted by regulatory authorities. Regrettably, the history of drug regulation is marred by several catastrophic events. One such incident is the Elixir Sulfanilamide tragedy, in which the toxic compound diethyl glycol was included in a sweet-tasting medication, leading to numerous fatalities. This event prompted the enactment of the Food, Drug, and Cosmetic Act in 1938. Under...
3.2K
01:01Dosage Regimens: Partial Pharmacokinetic Parameters
235
It is not uncommon for complete drug pharmacokinetic profiles to remain elusive in pharmacokinetics. This necessitates certain educated assumptions by pharmacokineticists to determine appropriate dosage regimens without comprehensive pharmacokinetic data from animal or human studies. One prevalent assumption is setting the bioavailability factor, denoted as F, to 1 or 100%. This assumption caters to the scenario where a drug doesn't achieve full systemic absorption, resulting in the patient...
235
01:26Therapeutic Drug Monitoring: Drug Analysis Methods
253
Therapeutic Drug Monitoring (TDM) is a clinical practice that measures specific drug levels in a patient's blood or body tissues to tailor drug therapy effectively. This monitoring is critical for managing drugs with narrow therapeutic indices like digoxin and phenytoin, ensuring they are both safe and effective. For instance, monitoring theophylline levels in asthma patients involves precision and sensitivity to adjust doses according to individual responses to therapy, ensuring efficacy and...
253
01:28Structure-Activity Relationships and Drug Design
1.9K
Drug design is a dynamic field that involves discovering and developing new medications based on specific biological targets. This process heavily relies on structure-activity relationships (SAR) and quantitative structure-activity relationships (QSAR) to guide the design and optimization of efficient drugs.
SAR studies the intricate relationship between a drug's chemical structure and biological activity. It focuses on understanding how modifications to a drug's structure can influence...
SAR studies the intricate relationship between a drug's chemical structure and biological activity. It focuses on understanding how modifications to a drug's structure can influence...
1.9K
01:29Therapeutic Drug Monitoring: Affecting Factors
299
Therapeutic Drug Monitoring (TDM) is the clinical practice of measuring specific drug levels in a patient's blood or body tissues to manage and optimize therapy. TDM is crucial for drugs with narrow therapeutic windows, like warfarin and phenytoin, where incorrect doses can lead to treatment failure or severe side effects. This monitoring ensures the dosage administered is within a safe and effective range. The factors affecting therapeutic drug monitoring include:Patient-Specific Factors:a.
299