This document provides high-level guidance and recommendations from the Global IDMP Working Group (GIDWG) on how to assign Pharmaceutical Product Identifiers (PhPIDs) to marketed medicinal products for human use. It is regularly updated as projects progress.
Presentations & Documents
U.S. FDA guidelines on IDMP implementation
The U.S. Food and Drug Administration (FDA) has released a guideline for industry titled “Identification of Medicinal Products—Implementation and Use”. This document outlines the FDA’s position and progress in aligning its standards with IDMP standards.
Identification of Medicinal Products—Implementation and Use – March 2023 [PDF]
UNICOM working paper on IDMP in ICSRs
A key aim of UNICOM is to improve the processing and analysis of individual case safety reports (ICSRs) that describe adverse drug reactions (ADRs). To achieve this, the organisation has released the working paper titled “IDMP Coding Principles and Guidance for ICSRs“.
This paper provides recommendations for practical IDMP implementation, such as PhPID generation, and for handling drug information in general, including grouping concepts and the use of name parts. These guidelines aim to improve ICSR data management and pharmacovigilance analysis.
UNICOM Gap Analysis on existing and new standards and profiles – UNICOM presentation for EFPIA PVEG WG
Work package 1 focuses on IDMP-related standards and terminologies, identifying gaps in existing standards and the need for new ones.