What is GIDWG?
The Global IDMP working group (GIDWG) was formed in Oct 2021 with the goal to pursue projects leading to the establishment of a framework for the global implementation of the ISO IDMP standards and maintenance of global identifiers.
GIDWG Introduction and Purpose
The Global IDMP Working Group (GIDWG) has been organized and chartered following several recommendations from the 2019 IDMP Workshop hosted in Geneva by WHO. The initial charter members include the European Medicines Agency, the U.S. Food and Drug Administration and the Uppsala Monitoring Centre. Additional regulatory agencies and stakeholders that have joined the effort are ANVISA, Health Canada, Swissmedic, EDQM, INN, USP and IFPMA. The GIDWG is an international organization with the mission to conduct and report on projects leading to the establishment of a framework for the global implementation of the ISO IDMP standards and maintenance of global identifiers and systems. GIDWG collaborates with ISO TC 215 WG6, HL7 groups, Pistoia alliance and works to propose, test and report on solutions to IDMP issues that are hurdles to global regulatory implementation and use.
The scope of GIDWG includes:
- Understand and develop consensus on the issues with the ISO IDMP standards and their Technical Specifications.
- Understand and develop consensus on solutions to mitigate the issues with the ISO IDMP standards and their Technical Specifications.
- Develop and prioritize a list of global IDMP implementation use cases.
- Understand the IDMP implementation status and challenges in each region.
- Understand and develop a consensus on what the best operating model would be for FDA-GSRS, EU-SRS, UMC SRS.
- Articulate and develop consensus on use of UMC as the organization for maintenance of global IDMP identifiers
- Develop a consensus on best practices, processes, operating model for maintenance of global identifiers for marketed medicinal products.
- Identify, recommend, and participate in pilot projects.
- Identify and recommend best approaches for communicating outcomes / summary of findings to other stakeholders.