Global Pharmacovigilance Observatory to aid pharma’s understanding of regulatory decisions

The UK’s Drug Safety Research Unit (DSRU) has launched a Global Pharmacovigilance Observatory to help the pharma industry understand why international regions reach different decisions on the use of medicines.

The observatory will review and collate pharmacovigilance and drug safety data, analyses, evaluations and decisions made in different countries or regions to help regulators and pharma companies pinpoint differences between regions and become better informed when considering drug safety issues.

Professor Saad Shakir, Director of the DSRU, stated: “While there are many similarities between national medicines regulators across the world, there are important differences in how each agency operates. A long-standing important issue is why different national regulatory authorities can reach different decisions.

“We hope our observatory will fill this knowledge gap and become a useful tool for the whole pharmacovigilance sector. It will pull together many parts of a complex picture to help us understand what is going on around the world and better inform us when debating drug safety decisions.”

According to the DSRU, there are numerous reasons as to why different regulatory decisions are reached, from the differences in health systems to diverse regulatory laws, processes and protocols. As such, thresholds for taking action, especially to spontaneous reports of adverse events, and regulatory decisions can vary.

In addition, measures to manage risk can also differ. For example, in some regions, regulators request a black triangle or ‘black box warning’ is added to prescribing information if they want additional safety monitoring, perhaps if the drug is new. But in other regions, this is not necessary.

While some differences in the decisions about marketing authorisations can be understood because of these complexities, it remains difficult to understand all the reasons for the discrepancies of major ‘post-marketing’ regulatory decisions.

By collating information from several regulatory authorities, including the US Food and Drug Administration (FDA) and European Medicines Agency (EMA), the observatory aims to improve the understanding of adverse drug reactions, while also increasing accuracy and enabling more advanced analyses, where appropriate, for events.

The DSRU also revealed that many of the analyses will be “living” and will be updated when new relevant information becomes available.