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 are 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. As FDA focuses on the challenges of the global supply chain and foreign sourcing of medicinal products, FDA continues to participate in the development of and to 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. MPID describes the detailed data elements and their structural relationships required for the unique identification of regulated medicinal products. Data elements that identify and characterize a medicinal product include the product name (authorized by regulatory agency), clinical particulars (e.g. indications, contraindications), pharmaceutical product (substance, dosage form, route of administration), medicinal product packaging, marketing authorization (e.g., authorization number, application information), manufacturer/establishment, etc.
- ISO 11616: Data elements and structures for unique identification and exchange of regulated pharmaceutical product information. PhPID uniquely associates medical products with the same or similar pharmaceutical composition based on the following data elements: substance(s), strength(s) (units of measurement/presentation), reference strength(s), and dosage form.
- ISO 11238: Data elements and structures for unique identification and exchange of regulated information on substances. Defines substances that constitute a medicinal product by their main, general characteristics.
- 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. Specifies rules for the usage of units of measurement, establishes requirements to provide for traceability to international metrological standards, defines requirements for representation of units of measurement in coded form, provides structures and rules for mapping between different unit vocabularies and language translations.
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 Individual Case Safety Reports (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 and terminologies similar to the concepts presented in the IDMP standards. We have assessed internal operations and systems and determined that many of the terminologies and standards currently used in regulatory submissions across the medical product development lifecycle are compatible with the data concepts in Medicinal Product Identification (U.S. National Drug Code), Substance Identification (Unique Ingredient Identifier), and Units of Measure (Unified Code for Units of Measure). FDA will continue to collaborate with ISO, as well as other regulatory agencies to identify and use a central list of dosage form and route of administration terms referenced in the ISO 11239 standard. Lastly, FDA will continue to collaborate internationally and to enhance its operations and systems, as needed, to ensure conformance to IDMP standards.