Pharmacovigilance compliance among Marketing Authorisation holders in Saudi Arabia

Around the world / 07 August 2023

The latest annual report of the SFDA reveals some interesting insights and next steps for pharmacovigilance compliance among MAHs.

In their relentless pursuit of safeguarding public health, in November 2018 the Saudi Food & Drug Authority (SFDA) launched the pharmacovigilance inspection program. Designed to oversee the activities of marketing authorisation holders (MAHs) and their agencies, these inspections have been instrumental in upholding safety standards and enforcing adherence to the Guideline on Good Pharmacovigilance Practices (GVP). As part of this program, an annual report is released, providing a comprehensive overview of inspection outcomes, and offering valuable guidance for improving pharmacovigilance compliance among MAHs.

From 1st January to 31st December, 2022, a total of 50 inspections were carried out under the pharmacovigilance inspection program. These inspections were categorised as routine, trigger, re-inspections, and second re-inspections. Throughout this period, a total of 253 findings were recorded (22 critical, 180 major, and 51 minor findings), reflecting a 3.5% rise compared to the previous reporting period. Although the number of critical findings decreased slightly, major findings saw a significant increase, with minor findings reaching their highest recorded value.

Among the critical findings, the majority were related to the qualified person responsible for pharmacovigilance, pharmacovigilance system master file, management and reporting of adverse reactions, and interviewee knowledge. The most prominent issue in the major finding category centred around failures in managing and reporting adverse reactions, accounting for 21.1% of all major findings. Deficiencies in signal management (13.9%) and the pharmacovigilance system master file and quality management system (11.1%) were also significant areas of concern. When it came to minor findings, the highest proportions were attributed to the qualified person responsible for pharmacovigilance (19.6%) and the quality management system (15.7%), followed by the risk-management system (13.7%) and written instructions (SOPs, manuals, etc.) (11.8%).

In addition to inspections, the dedicated inspection team conducted a satisfaction survey among the inspected MAHs, covering the period from 2018 to mid-2022. Out of 70 participants, 42 responded to the survey. The overall outcome of the survey indicated a range between satisfied and very satisfied, highlighting a positive reception of the inspection program and its effectiveness in fostering compliance.



The pharmacovigilance inspection program remains committed to employing a risk-based approach in its inspection schedule. By prioritising high-risk areas for inspection and emphasising regulatory compliance, the program continues to make significant strides in protecting public health. The annual report serves as a vital tool, equipping MAHs with insights and best practices to enhance their pharmacovigilance compliance.

Article written with contributions from Mobarak Al Shahrani, National Pharmacovigilance Center Director, Executive Directorate of Pharmacovigilance, Saudi Food and Drug authority.

Amal Arafah @Saudi_FDA
Expert Pharmacovigilance system inspector, Saudi Food and Drug Authority

Abdullatif A. AlOtaibi @Saudi_FDA
Head of Pharmacovigilance inspection section, Saudi Food and Drug Authority

Hammad A. Al Dali @Saudi_FDA
Expert Pharmacovigilance system inspector, Saudi Food and Drug Authority

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