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13 Dec 2017

What is ISO IDMP standards? What it’s importance in drug regulation point of view?

IDMP stands for identification of medicinal products 

  • The European Medicines Agency (EMA) is in the process of implementing the standards developed by the International Organization for Standardization (ISO) for the identification of medicinal products (IDMP).
  • EMA is implementing the standards in a phased programme based on the four domains of master data in pharmaceutical regulatory processes: substance, product, organisation and referential (SPOR) master data.
  • The ISO IDMP standards specify the use of standardised definitions for the identification and description of medicinal products for human use.
  • Their purpose is to facilitate the reliable exchange of medicinal product information in a robust and consistent manner.
  • They help to ensure wide interoperability across global regulatory and healthcare communities, which is critical in ensuring accurate analysis and unambiguous communication across jurisdictions.

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