IDMP ISO Standards

The purpose of these standards is to facilitate the reliable exchange of medicinal product information in a robust and consistent manner, by providing a common product ’language’ for stakeholders to use in their interactions. The use of these standards is a regulatory requirement as they are mandated by the EU legislation (Commission Implementing Regulation (EU) No 520/2012 [articles 25 and 26]).

 

5 Standards

ISO IDMP comprises five separate standards. These standards establish definitions and concepts and describe data elements and their structural relationships. They cover the following aspects to describe a medicinal product:

  • Medicinal product name;
  • Ingredient substances;
  • Pharmaceutical product (route of administration, strength);
  • Marketing Authorisation;
  • Clinical particulars;
  • Packaging;

ISO IDMP covers the entire product lifecycle: products in development, investigational products, products under evaluation and authorised products.

Pharmacovigilance
Pharmacovigilance

Scope of the ISO IDMP

ISO IDMP is composed of five separate standards, with following scope :

  • All Pharmaceutical companies with EU Marketing Authorization must comply with IDMP Regulation and submit their Medicinal Product data to EMA
  • IDMP Standards are applicable to both Human Medicines (Authorized & Investigational) and Veterinary Products
  • All Bio-Pharma (Innovators/Generics), Consumer Healthcare and Veterinary products are under scope

Cross-functional standards

ISO IDMP has multiple use cases within the regulatory context. For example:

  • Pharmacovigilance: Adverse event reports are based on a harmonised set of product definitions, improving the quality of data used for signal management, and speeding up communication, decision-making and actions;
  • Regulatory submissions: Submissions use a consistent standard to capture and manage data, allowing information on medicinal products to be shared and re-used across different procedures and among various regulators (subject to confidentiality restrictions);
  • Clinical trials: Stakeholders can access Clinical Trial data using agreed and well-supported standards, improving the assessment and scientific evaluation of medicines as well as communication and transparency;
  • Good Manufacturing Practices (GMP) inspections: Inspections on manufacturing sites are based on accessible information, which streamlines inspections particularly for urgent situations involving defects. Faster detection of falsified medicines can also be supported because of consistent data standards.
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