It has, since 2012, been a well-established fact that pharmaceutical
companies which have medicinal products or are conducting
clinical trials in the European Union (EU) will have to adhere to
the ISO standards mandated in EU Regulation 520/2012. With the
aim of improving overall pharmacovigilance signal detection and
oversight, the European Medicines Agency (EMA) will rely on these
standards (11615, 11616, 11238, 11239 & 11240) to achieve this
goal. Niels Grønning and Rune Ringsholm Bergendorff at NNIT
give us an insight into the data volume of an ISO IDMP submission.