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Healthcare databases are very useful sources of post-marketing real-world information, generating evidence on drug use, safety and effectiveness, particularly in populations where such information may be lacking in pre-clinical studies, such as paediatric and geriatric populations. However, healthcare databases can also provide pre-marketing information by measuring the burden of disease, identifying unmet clinical needs and estimating the number of patients potentially eligible for innovative and costly treatment. Whether in a pre- or post-marketing setting, these data sources can provide regulatory agencies with evidence that can inform the development/implementation of regulatory interventions and answer questions of high, and often urgent, public health interest. In April 2019, the Italian Drug Agency (Agenzia Italiana del Farmaco) organised a workshop on the role of healthcare databases in supporting drug regulatory agencies in their pre- and post-marketing regulatory activities. The experiences of the USA, Canada, Spain and Italy in this context were presented.