Europe – EMA spells out data access policy for shortage monitoring platform

On Monday, the European Medicines Agency (EMA) issued a new data access policy, elaborating on the differing levels of data access available to different stakeholders via the European Shortages Monitoring Platform (ESMP).

Under this categorization scheme, stakeholders, including the general public, patients and consumers, and academia, will have Level 1 access; marketing authorization holders and their contractors and vendors will have Level 2 access; National Competent Authorities (NCAs) will have Level 3 access; and EMA and the European Commissioner will have the highest-level access to potentially sensitive information…