What is the Identification of Medicinal Products (IDMP)?

What is the Identification of Medicinal Products (IDMP)?

The Identification of Medicinal Products (IDMP) is a comprehensive set of international standards developed by the International Organization for Standardization (ISO) in collaboration with the International Council for Harmonisation of Technical Requirements of Pharmaceuticals for Human Use (ICH). The set of standards provide a standardized framework that supports the unique identification of products and facilitates the exchange of information between key stakeholders such as global regulators, manufacturers, suppliers, and distributors. The IDMP consists of 5 standards:

Five IDMP Standards

ISO 11615: Medicinal Product Identification: provides detailed data elements and structural relationships necessary for uniquely identifying regulated medicinal products. It includes information like product names, clinical particulars, pharmaceutical product details, packaging, marketing authorizations, and manufacturer information.

ISO 11616: harmaceutical Product Identifier (PhPID): Pdefines data elements and structures for uniquely identifying and exchanging information about pharmaceutical products. It associates medical products based on pharmaceutical composition, including substances, strengths, reference strengths, and dosage forms.

ISO 11238: Substance Identification (SubID): outlines data elements and structures for the unique identification of substances that constitute medicinal products based on their general characteristics.

ISO 11239: Dosage Form and Route of Administration: covers data elements and structures for uniquely identifying and exchanging information related to pharmaceutical dose forms, units of presentation, routes of administration, and packaging.

ISO 11240: Units of Measurement (UoM): specifies rules for the usage of units of measurement, ensuring traceability to international metrological standards, and providing structures and rules for mapping between different unit vocabularies and language translations.

These standards are crucial for harmonizing the global regulatory landscape, enabling the consistent identification and documentation of medicinal products, and enhancing the safety and efficacy of pharmaceuticals across the world

Advantages of Identification of Medicinal Products (IDMP)

Some of the benefits associated with the IDMP contribute towards enhanced safety surveillance, transparency, interoperability, and mitigating drug shortages. For example, the unique identification of medicinal products in ICSRs and detection of global safety signals referenced in AEs will help improve pharmacovigilance. Communication of product data on a global scale and building trust with various stakeholders for product quality & safety help in maintaining product transparency. The IDMP standards also enable identification of pharmaceutical equivalent products across the globe to help reduce shortages in drugs.

How Does Idmp Cover the Product Lifecycle?

The IDMP standards can be applied to multiple stages of the regulatory product lifecycle including drug development, products under review, authorized products, etc. In addition to making pharmacovigilance more efficient and increasing transparency, IDMP standards contribute towards regulatory submissions. They facilitate the exchange of consistent information associated with medicinal products between key stakeholders that could be used for various regulatory procedures. This would reduce duplicate work that may be required in regulatory affairs.