Produced by Uppsala Monitoring Centre (UMC), this film gives an overview of how Pharmaceutical Product Identifiers (PhPIDs) are created and assigned to medicinal products.
PhPIDs are a key part of the IDMP standards and will have a significant impact on how pharmacovigilance is carried out, and will contribute to the safer use of medicines globally.
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]
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.
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.
