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:
- ISO 11615 : Data elements and structures for unique identification and exchange of regulated medicinal product information
- ISO 11616 : Data elements and structures for unique identification and exchange of regulated pharmaceutical product information
- ISO 11238 : Data elements and structures for unique identification and exchange of regulated information on substances
- ISO 11239 : Data elements and structures for unique identification and exchange of regulated information on pharmaceutical dose forms, units of presentation, routes of administration and packaging
- ISO 11240 : 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 : Implementation technical specification for ISO 11615
Pharmaceutical Product Identification
- ISO TS20451 : Implementation technical specification ISO 11616
Substance Identification (SubID)
- ISO TS19844 : Implementation technical specification for ISO 11238
Dosage Form and Routes of Administration (DF & RoA)
- ISO TS20440 : Implementation technical specification for ISO 11239
The benefits of IDMP include:
- 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.
- 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.
- 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.