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New research project aims to improve understanding of differing decisions on medicine use




A new research project, announced by the UK’s Drug Safety Research Unit (DSRU), will aim to improve understanding of differing decisions on medicine use between different countries and regions.

The Global Pharmacovigilance Observatory will review pharmacovigilance and drug safety data, as well as analyses, evaluations and decisions made in different countries.

The resulting information will be collated with the goal of helping regulators and pharma companies to identify differences between regions and improve their understanding of drug safety issues.

In a statement, the DSRU said that while some differences in decisions can be understood, in relation to differences between health systems and varying measures to manage risk, it is difficult to understand all the reasons for discrepancies in major post-marketing regulatory decisions.

“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,” said Saad Shakir, director of the DSRU.

“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,” he added.



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