RIYADH, Nov 3: Pharmacovigilance is the process of monitoring the safety of medicines after they are approved for public use. It plays an important role in detecting, assessing, understanding, and preventing adverse effects or other drug-related problems. As healthcare improves around the world, many countries are still working to strengthen their drug safety system and bring them in line with international standards. Saudi Arabia is also a part of this global effort and is actively participating in improving its pharmacovigilance framework in a way that meets both global expectations and the specific needs of its local healthcare sector.

This article compares the global pharmacovigilance standards with the practices followed in Saudi Arabia. It highlights similarities, differences, and areas where the Kingdom has made progress or still faces challenges.

Global Pharmacovigilance Practices and Guidelines

Globally, pharmacovigilance is governed by a set of established guidelines and best practices. The bodies that set these standards include the World Health Organization (WHO), the European Medicines Agency (EMA), the U.S Food and Drug Administration (FDA), and the International Council for Harmonisation (ICH). They make sure that medicines are safe, effective, and closely monitored after they reach the market.

To achieve this, the focus is on several key areas. One is the reporting of adverse drug reactions (ADRs) which means any problem caused by the medicine must be reported by the doctors, patients, or drug companies.

Another area is risk management. This includes identifying risks early and taking steps to minimize them. Regular safety updates from pharmaceutical companies are also required, which are then reviewed by the regulatory bodies.

Technology has also become a part of how these systems work. Databases and digital platforms allow for faster collection and analysis of safety data. Some countries also use artificial intelligence tools to identify patterns in adverse event reports. Regulators encourage patient-centered approaches where patients are also a part of the safety conversation and should understand how to report problems with their drugs promptly.

Saudi Arabia’s Pharmacovigilance Framework

In Saudi Arabia, pharmacovigilance is overseen by the Saudi Food and Drug Authority (SFDA). Over the past few years, it has made major progress in building a strong pharmacovigilance system. The authority now works with local and international stakeholders to improve drug safety and build trust in the healthcare system.

In the recent few years, Saudi Arabia has introduced several policies to bring its pharmacovigilance system in line with international expectations. These include mandatory reporting rules for pharmaceutical companies and healthcare institutions. The SFDA also collects reports from healthcare professionals and the public. It maintains a national database of adverse drug reactions, similar to the global systems used in Europe and the United States.

One of the key developments has been the training and education of healthcare professionals. The SFDA has been working to raise awareness about the importance of reporting adverse events. This includes campaigns, workshops, and training sessions for doctors, pharmacists, and nurses. The goal is to make pharmacovigilance part of everyday healthcare practice.

Saudi Arabia has also been investing in technology to improve drug safety monitoring. SFDA has launched an electronic platform called the Saudi Adverse Event Reporting System (SAERS) to collect and manage reports. It is also working with hospitals and pharmaceutical companies to make digital reporting as the standard. These efforts are helping to make the system faster, more transparent, and easier to use.

Saudi Compliance with Global Pharmacovigilance Standards

Saudi Arabia’s pharmacovigilance system shares many similarities with global standards. One clear correspondence is the structure of the reporting system. Similar to Europe and the United States, SFDA in Saudi Arabia requires that all serious and unexpected adverse drug reactions be reported promptly. The format and timelines of the reporting are also aligned with international expectations.

Another similarity is the focus on risk management. Just as global regulatory bodies require companies to submit risk management plans, SFDA asks pharmaceutical companies to provide detailed strategies on how they plan to monitor and reduce risks. These plans are reviewed regularly, and companies are held accountable for their implementation.

Saudi Arabia has also adopted the practice of periodic safety updates. These are regular reports submitted by companies that include information on all known safety issues and any new risks that have been identified. This allows SFDA to stay informed and take timely action if needed.

Differences Between Global and Saudi Pharmacovigilance Practice

Despite these similarities, there are still differences between the global pharmacovigilance system and that of Saudi Arabia. One of the main differences lies in the maturity of the systems. Countries like the United States and Europe took years to refine their practices and standards. Their systems are well-integrated into healthcare and supported by large networks of trained professionals.

In contrast, Saudi Arabia is still building its framework capacity. While great progress has been made, the culture of pharmacovigilance is still developing. For example, in some hospitals, there are still some gaps in adverse drug reaction reporting due to a lack of awareness or time constraints among healthcare workers. More education and support are needed to fully embed pharmacovigilance into the healthcare workflow.

Another difference is the volume of data. Countries with larger populations and more developed pharmaceutical industries tend to collect more reports. This gives them a larger database to work with when looking for safety signals. Saudi Arabia, with a smaller population and fewer local manufacturers, collects fewer reports, which limits early detection in some cases.

There are also regulatory and legal differences. Global bodies like the European Medicines Agency (EMA) operate under a regional framework that allows member states to share data and coordinate actions. On the other hand, Saudi Arabia operates independently. Although it actively engages in international collaboration, data sharing and coordination across borders are still developing.

Bridging the Gap Between KSA & Global Pharmacovigilance Standards

Efforts are already underway by Saudi Arabia to improve and align its pharmacovigilance framework with global standards. The authority has signed cooperation agreements with international regulators. This allows the exchange of information and best practices. The Kingdom is now also part of the WHO Programme for International Drug Monitoring which gives SFDA access to global safety databases and helps it keep pace with global developments.

Locally, the government is supporting investment in education and training. Medical and pharmacy schools are including pharmacovigilance in their curriculums. Continuing education programs for working professionals are being expanded. These steps aim to build a culture of safety where reporting and monitoring become second nature.

Public awareness is another focus. SFDA is running national campaigns to encourage patients to report side effects. This is in line with global efforts to make pharmacovigilance more inclusive. By involving the public, the system becomes stronger and more responsive.

Saudi Arabia is also encouraging local pharmaceutical companies to build their internal pharmacovigilance systems. This includes hiring dedicated staff, using safety databases, and reporting in line with international standards. These requirements are part of the broader strategy to make the local industry more competitive and trusted. Companies also seek support from licensed consultancies such as PharmaKnowl Consulting, which help guide firms through local and global pharmacovigilance & QPPV requirements, regulatory submissions, and compliance practices.

Future Outlook for Saudi Arabia’s Pharmacovigilance System

Pharmacovigilance is not a one-time effort. It is an ongoing process that grows with new medicines, technologies, and patient needs. For Saudi Arabia, staying aligned with global standards means continuously updating its policies, investing in people, and using the best tools available. The future is promising, especially as more stakeholders from hospitals to manufacturers and patients become active participants in drug safety.