Quote from VigiServe Admin on December 24, 2020, 1:27 PM

IDMP is a suite of five standards developed within the International Organization for Standardization (ISO).  These standards provide an internationally-accepted framework to uniquely identify and describe medicinal products with consistent documentation, coding and exchange of product information between global regulators, manufacturers, suppliers and distributors.  The IDMP suite of standards is a result of a need to standardize the definition of medicinal product and substance information to facilitate the unique identification and exchange of such information in the context of pharmacovigilance.

Scope of the ISO IDMP standards

The five standards provide data elements and structures to uniquely identify and exchange information on:

• substances (ISO 11238);

• pharmaceutical dose forms, units of presentation, routes of administration and packaging (ISO 11239):

• units of measurement (ISO 11240);

• regulated pharmaceutical product information (ISO 11616);

• regulated medicinal product information (ISO 11615).

These standards cover the following aspects to describe a medicinal product for human use:

• medicinal product name;

• ingredient substances;

• pharmaceutical product (route of administration, strength);

• marketing authorisation;

• clinical particulars;

• packaging;

• manufacturing.

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

The benefits of IDMP include:

Safety Surveillance

• Unambiguous global identification will improve pharmacovigilance by uniquely identifying specific medicinal products in Individual Case Safety Reports (ICSRs).

• Globally detect safety signals from medicinal products referenced in adverse events.

Transparency

• Communicate medicinal product data globally.

• Opportunity to communicate and build trust with the public and other stakeholders about medicinal product quality and safety.

Mitigation of Drug Shortages

• Standard allows us to identify pharmaceutically equivalent products across regions, to support mitigation of drug shortages.

Interoperability

• Harmonized source for product information based on vocabularies and standards that are consistent across the globe.

• Support the exchange of medicinal product information between companies and regulators.