Data Standardisation Strategy stakeholder workshop

EMA has launched an initiative to develop a data standards strategy, with a view to addressing the HMA/EMA Big Data Task Force recommendation to engage in international initiatives related to data standardisation. 

The strategy will enable the European medicines regulatory network to leverage data  more effectively to deliver evidence in support of benefit-risk decision-making on the development, authorisation and use of medicines. The intention is to optimise the processing of such data by different stakeholders through improved submission formats tailored to their needs, while ensuring data security.

EMA plans to consult a wide range of stakeholders to understand their data standardisation needs related to the submission, receipt, use and re-use of scientific data at each stage of the medicinal product lifecycle.