OBJECTIVES: On September 16, 2021, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) approved guidelines for use of patient registries by marketing authorisation applicants and holders (MAAs/MAHs) to support regulatory decision-making. The Nordic countries are globally renowned for the depth, breadth, and quality of local real-world data (RWD). This research aims to assess the suitability of Nordic RWD to support EMA regulatory decision making.

METHODS: Based on the checklist for evaluating suitability of registries for registry-based studies available in the guideline, an assessment of Nordic RWD characteristics was made. Each criterion was assessed alongside key factors impacting the assessment.

RESULTS: The Nordic countries have a long history of register-based research, resulting in a research environment that is transparent, robust and well-structured. Nordic RWD can be classified into administrative registries where data was collected for reasons other than healthcare research (secondary data) and those collected to monitor and improve healthcare, usually including patients based on disease or medical interventions (primary data). Administrative registries are likely to fulfil the EMA’s suitability checklist across both the administrative and methods dimensions due to the data environment’s high levels of transparency, centralisation and governance, extensive usage and validation, and established processes and documentation. There is more diversity in the suitability of primary data registries. For example, mature primary data registries will have close to full population coverage while maturing registries will typically have partial coverage, which may result in selection bias.

CONCLUSIONS: MAAs/MAHs assessing registry data sources that support good regulatory practices, as set out by the EMA, should consider the use of Nordic RWD. The EMA checklist helps to evaluate the suitability of registries in many dimensions, but other factors such as the portability of findings to other healthcare settings should also be considered.