As defined in the Joint HMA-EMA Network Data Steering Group mandate, the European medicines regulatory network handles a wide spectrum of data that is received, processed, generated, managed and analysed to ensure that decisions on medicines are well-informed and evidence based.
Such data include:
• Regulatory submissions data – sent by marketing authorisation holders or applicants to demonstrate the safety, efficacy, and quality of a medicine.
• Substance, product, organisation and referential (SPOR) master data – essential for the network’s cross operations including the monitoring of medicines’ safety and shortages.
• Real-world data such as electronic health records, patient registry data or datasets from spontaneously reported suspected adverse drug reactions to complement the evidence from clinical trials and fill knowledge gaps regarding a medicine.
Data from the regulatory business are made available to the health care sector where they can use it as master data e.g. Product Management System (PMS). Data from the health care sector can be used to generate evidence and support regulatory business, academia, and policy makers. The secondary use of health care data is further enhanced if the regulatory master data has been used.
Regarding processes, the EMRN can oblige itself to follow the principles described in this strategy.
This strategy is intended for the members of the EMRN and will help clarify the roles and responsibilities of the members that manage network data assets on behalf of the EMRN. For data created by external stakeholders, the EMRN will set general requirements, validate the quality and the format of the data, and the accompanying documentation.
Existing requirements for the processes applied by external stakeholders to create and manage the data the EMRN receives are
not affected by this strategy.