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.
September 2024: Global IDMP Working Group (GIDWG) yearly stakeholders’ meeting at Brazilian Health Regulatory Agency
Our past conferences have been full of valuable information and great networking opportunities. We expect this year to be the same. Welcome to our 4th Global IDMP Working Group (GIDWG) Stakeholder Meeting, planned for the third week of September 2024, hosted by the Brazilian Health Regulatory Agency (Anvisa) in Brazil.
UPDATE: Thank you to everyone who attended the 4th GIDWG Technical and Stakeholder Meeting for making it such a success. It provided an excellent platform to further our shared vision of global IDMP implementation.
Presentations materials:
End-to-end demonstration Q4 2023–Q2 2024
Testing of use cases for PhPID operating model
PURPOSE
To test the framework, including business rules, best practices, software, and operating model, for global IDMP implementation and maintenance of global identifiers for marketed products.
SCOPE
• Validate and generate PhPIDs for medicinal products based on GIDWG/EWG Business Rules
• EDQM and non-EDQM countries
• Similar products from different countries
• Larger batches and smaller data sets for regulators
• Test use cases for pharmacovigilance, drug shortages, and cross-border healthcare
STATUS
Completed
Global IDMP PhPID End-to-End Testing report, 5 December 2024
19–20 October: CTADHL sixth transatlantic workshop
This workshop will bring together experts involved in various aspects of IDMP implementation worldwide, from product development to regulatory processes, clinical use, and outcome assessments.
18 October: Global IDMP Working Group (GIDWG) stakeholders’ public meeting
Welcome to our 3rd Global IDMP Working Group (GIDWG) Stakeholder Meeting.
GIDWG’s mission is to establish a framework for global implementation of ISO IDMP standards and maintenance of global identifiers.
The GIDWG will report on 5 pilot projects:
- Substance Identifiers
- Dose form Identifiers
- Strength Definitions Identifiers
- Operational Model
- FHIR for information exchange.
These projects cover global use cases including pharmacovigilance, drug shortages, and cross-border healthcare.
Presentation materials:
IDMP webinar – Current status and the road to implementation
Uppsala Monitoring Centre (UMC) sees IDMP as a game-changer for pharmacovigilance. It establishes a common language and enables the effective exchange of vital medicinal product data throughout the drug development and regulatory lifecycle. By standardising data exchange, IDMP improves our ability to identify, evaluate, and manage risks associated with medicinal products. In a one-hour webinar on 14 June 2023, UMC will discuss the current status of IDMP and collaboration efforts to implement the standards.
UPDATE: Recordings of the webinar are now available:
Podcast explains IDMP standards
The IDMP standards aim to harmonise how pharmaceutical products and substances are described globally. But how will that benefit patients and who will make sure the standards are properly implemented? Uppsala Monitoring Centre’s Malin Fladvad and Olle Lagerlund discuss the advantages and challenges of this global standardisation effort in the Drug Safety Matters podcast.
23-25 October: Global Pharmaceutical Regulatory Affairs Summit
From 23-25 October 2023, UNICOM will present the results of work package 2 related to substances. For more details, see the UNICOM website.
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.