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Identification of Medicinal Products (IDMP)

Identification of Medicinal Products (IDMP)

IDMP is a suite of five standards developed within the International Organization for Standardization (ISO) which 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.

As FDA focuses on the challenges of the global supply chain and foreign sourcing of medicinal products, we continue to participate and promote the adoption of international harmonized IDMP to ensure the safety of medications throughout the world. 

The five IDMP standards are:

Medicinal Product Identification (MPID)

  • ISO 11615 disclaimer icon:  Data elements and structures for unique identification and exchange of regulated medicinal product information

Pharmaceutical Product Identifier (PhPID)

  • ISO 11616 disclaimer icon:  Data elements and structures for unique identification and exchange of regulated pharmaceutical product information

Substance Identification (SubID)

  • ISO 11238 disclaimer icon: Data elements and structures for unique identification and exchange of regulated information on substances

Dosage Form and Routes of Administration (DF & RoA)

  • ISO 11239 disclaimer icon:  Data elements and structures for unique identification and exchange of regulated information on pharmaceutical dose forms, units of presentation, routes of administration and packaging

Units of Measurement (UoM)

  • ISO 11240 disclaimer icon:  Data elements and structures for unique identification and exchange of units of measurement

Technical specifications - Implementation guide for relevant IDMP standards:

Medicinal Product Identification (MPID)

  • ISO TS20443 disclaimer icon: Implementation technical specification for ISO 11615

Pharmaceutical Product Identification

  • ISO TS20451 disclaimer icon: Implementation technical specification ISO 11616

Substance Identification (SubID)

  • ISO TS19844 disclaimer icon: Implementation technical specification for ISO 11238

Dosage Form and Routes of Administration (DF & RoA)

  • ISO TS20440 disclaimer icon: Implementation technical specification for ISO 11239

The benefits of IDMP include:

Safety Surveillance

  • Unambiguous global identification will improve pharmacovigilance by uniquely identifying specific medicinal products in 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.

FDA’s Approach to IDMP Standards

FDA has been using standards similar to the concept of IDMP.  We have assessed internal operations and systems and determined that terminologies and standards currently used in regulatory submissions across the medical product development lifecycle are compatible with the data concepts in each of the five ISO standards.  We are continuing to enhance our operations and systems to conform to IDMP standards.