This document is high-level guidance and presents the recommendations of the Global IDMP Working Group (GIDWG) for business rules on assigning Pharmaceutical Product Identifiers (PhPIDs) to marketed medicinal products for human use. This document is a work in progress and is regularly updated as the projects advance.
Presentations & Documents
US FDA guidelines on IDMP implementation
The US Food and Drug Administration (FDA) has released a guideline on IDMP for industry entitled “Identification of Medicinal Products—Implementation and Use”. This guidance explains FDA’s position and progress on aligning the Agency’s standards to Identification of Medicinal Products (IDMP) standards.
Identification of Medicinal Products—Implementation and Use – March 2023 [PDF]
UNICOM working paper on IDMP in ICSRs
A key UNICOM aim is to improve the processing and analysis of individual case safety reports (ICSR) that describe one or more suspected adverse drug reactions (ADRs) that occur in a single patient. To this end, the organisation has released the working paper “IDMP Coding Principles and Guidance for ICSRs“.
The working paper provides recommendations for practical IDMP implementation aspects (for example, PhPID generation) and for handling drug information in general (such as grouping concepts, use of name parts), aimed at improving ICSR data management and pharmacovigilance analysis.
UNICOM Gap Analysis about Existing and New standards and ProfilesUNICOM presentation for EFPIA PVEG WG
Work package 1 focuses on IDMP-related standards and terminologies; its first deliverable is concerned with gaps in existing standards and profiles, and the arising need for adapted and new ones.