The World Health Organization (WHO) maintains a database globally called the “WHO Global Individual Case Safety Reports (ICSRs) Database,” also identified as “VigiBase.” This is principally a repository for data on pharmacovigilance. A pivotal role is played by the WHO repository in global clinical trials and as well as on all the marketed pharmaceutical products. VigiBase provides a centralized database for collecting and analyzing data on safety and adverse events. A diverse population of patients is involved in global clinical trials differing in lifestyles, genetic backgrounds, and practices of healthcare. In the space of global clinical trials, sharing of data and collaboration are necessary for the advancement of medical knowledge and improving outcomes of patients. The WHO’s pharmacovigilance repository nurtures collaboration among research professionals, pharmaceutical manufacturers, regulatory agencies, and healthcare specialists by acting as a fundamental hub for the data on pharmacovigilance. Healthcare experts as well as pharmaceutical manufacturers must ensure compliance with regulations of pharmacovigilance in reporting such occurrences to the repository via national programs on pharmacovigilance. Pharmaceutical manufacturers depend on VigiBase, for their product’s post-marketing surveillance. The WHO’s pharmacovigilance repository assists in the detection of signals and assessment of risk by data aggregation from these trials. Pharmacovigilance is the science and activities associated with the detection, assessment, understanding, and prevention of adverse effects or any other problem related to the drug.
VigiBase being one of the enormous databases of its kind worldwide, gathering side effects and adverse events reports linked with medicines and vaccines. Its management is done by the WHO Collaborating Centre for International Drug Monitoring, located in Sweden at the Uppsala Monitoring Centre (UMC). The (UMC) is the WHO Collaborating Centre for International Drug Monitoring. They help in the management of VigiBase and present a multitude of information on pharmacovigilance, safety of a drug, and their actions pertaining to the monitoring of medicines safety worldwide.
Some of the important points on VigiBase are depicted below:
- Purpose: The central repository for individual case safety reports (ICSRs) is VigiBase associated with side effects and adverse events associated with medicines and vaccines. The submission of these reports is done by national centres on pharmacovigilance, pharmaceutical manufacturers, healthcare experts, and patients.
- Collection of Data: Reports of adverse reactions under suspect from medicines and vaccines worldwide is collected and stored by VigiBase providing important facts on the prospective issues of safety linked with particular medications or vaccines.
- Global Reach: VigiBase has contributions from 130 member countries and more thus has a global reach. This data in a wide range allows safety trends analysis globally.
- Regulatory Support: VigiBase provides on time and comprehensive data on adverse events thus supporting regulatory decision-making. Data from VigiBase may be used by regulatory authorities worldwide for decision making on the approval, labeling, and monitoring of medicines and vaccines.
In conclusion, VigiBase stands as a foundation within the WHO’s pharmacovigilance repository, performing an important responsibility in safeguarding the health of public globally. As an inclusive database of data on safety and adverse events, it presents a platform for improved monitoring of safety, detection of signals, and assessment of risk across distinct populations of patients engaged in clinical trials globally. It also extends its role in supporting pharma manufacturers in compliance with regulatory requirements and post-marketing surveillance. By encouraging collaboration and sharing of data among investors, VigiBase not only toughens the pharmacovigilance efforts integrity but also helps in the promotion of trust and transparency within the communities of healthcare and global research. In the process of continuing the navigation of the drug safety’s complexities, VigiBase remains a fundamental resource in the pursuit of safer medicines and developed outcomes for patients globally.
