What is IDMP?
IDMP aims to improve patient safety in medication and will soon become mandatory for every Marketing Authorisation Holder (MAH) operating within the EU region. To achieve IDMP compliance in the region, companies must comply with five ISO standards.
The five ISO standards describes how to structure data on medicinal products according to defined information models. The collective goal for the standards (11238, 11239, 11240, 11615, and 11616) is to globally standardize the identification of medicinal products. Once EMA implements the new standards, FDA is expected to introduce the same requirements – making IDMP a worldwide standard.
Companies with products or ongoing trials in the European Union will be required to submit data to the European Medicines Agency (EMA) once the IDMP standards have been implemented. The US Food and Drug Administration (FDA) is expected to follow.