Blog: DSRU Global Pharmacovigilance Observatory – An Introduction
Samantha Lane and Saad Shakir
03 February 2021
There are a number of broad similarities between national medicines regulators across the world, however there are also important differences in how each agency operates. A long-standing important issue is why different national regulatory authorities can reach different decisions. One factor is that countries can have different health systems and different regulatory schools. While some differences in the decisions about marketing authorisations can be understood because of the complexity of healthcare systems, societal differences, and marketing plans by pharmaceutical companies, it can be more difficult to justify many, if not most, major pharmacovigilance decisions.
Regulatory authorities around the world handle spontaneous reports of suspected adverse drug reactions differently. Differences include methods for signal detection and communication. For example, for vaccines and medicines for COVID-19 some plan to publish regular summaries of reports they receive, while other agencies are not disseminating this information.
The DSRU Global Pharmacovigilance Observatory brings together outputs from several regulatory authorities into one place. This is important for improving the understanding of adverse drug reactions; bringing reports into one document increases the numbers, allowing for higher accuracy and more advanced analyses where appropriate. Many of the analyses will be "living" which will be updated when new relevant information becomes available. The DSRU Global Pharmacovigilance Observatory will fill a knowledge gap which has been needed for many years.