Masterarbeit

Analyzing the Global Implementation Efforts of the ISO Identification of Medicinal Products Standard - What is needed for consistent Progress?

Dr. Felix Spenkuch (2025)

Summary 

Language: English 

Although the first versions of the ISO IDMP standards have been defined in 2012, a truly global implementation is not on the horizon 13 years later. Applying literature search and expert interviews with industry representatives, this thesis investigates the state of progress of IDMP implementation globally, it assesses the hurdles encountered by industry and regulators and discusses potential drivers of a global implementation. The complications of an IMDP implementation in the EU that encompasses all member states is discussed specifically.

The global progress IDMP implementation of the regulatory authorities of Brazil, Canada, the EU, Switzerland, and the USA as well as the challenges that these agencies are facing in the process is analyzed based. The perspective of the pharmaceutical industry is added by considering an IDMP implementation benchmark collected by the Pistoia Alliance. Lastly, three expert interviews contribute personal experiences and opinions as well as insights into IDMP-related developments at both parties.

The results of this thesis demonstrate that the implementation of ISO IDMP standards suffers from technical barriers, political influences, and stakeholder misalignment. However, the significant potential for global harmonization remains real and ambitious countries like Switzerland, Canda, and Brazil may be able to leapfrog based on the groundwork laid by Europa and the United States. If a country could shortcut from the decade-long and still ongoing implementation journeys of EU and US others would be motivated to follow. 

Regarding the European IDMP implementation it has been determined that the past experiences with xEVMPD can inform the European IDMP implementation, as the challenges seem to be repeating regarding data ownership, data quality, and validation. With the go-live of PMS and with the continuous integration of the system into regulatory processes EMA has achieved an important milestone in its IDMP implementation. While the complex regulatory environment of the EU poses a continuous challenge, collaborative initiatives like the NDSG and the IDMP Community of Experts, the latter as a successor to the UNICOM project,  are positive developments toward a phased broader participation of national regulatory authorities across Europe that respects differing capacities, capabilities, and requirements form member state to member state.

This phased IDMP implementation in the EU is unfortunate from industry and patient perspective, since the full potential of IDMP, and the one of structured medicinal product data in particular, can only be leveraged once all EU NCAs have adopted the standard fully. To let member states of lesser capabilities and capacities profit from the progress of others will remain an important task toward an eventual EU-wide implementation of IDMP.

Interesting, the results show that industry and authorities are facing the same challenges in their IDMP journey which concern resources, data governance, and data quality, as well as suitable technical environments. The acceptance of the standard may hinge on uses cases that provide maximum value to industry and patients alike instead of focusing on politics-driven use cases like the ESMP in the EU. Collaborative digital environments like those of Accumulus Synergy and US FDA’s PRISM have the potential of providing such a value by defining a pan-national target operating model of IDMP but require clearer timelines regarding their IDMP implementations and broader access. The same goes for the IDMP Ontology which not only holds the potential to accelerated ISO IDMP standard development but also to ease change management and implementations — all provided the current limits of a commercial product status can be overcome.

Based on the interview of an ISO IDMP topic group member it could be confirmed that IDMP standard development is inherently slowed by structural constraints within ISO, like the reliance on voluntary contributions and consensus-driven decision-making, but also by the political agendas of every contributing country, as well as by the complexity of the standards themselves. However, a global standard can only ever work, if requirements are met wherever possible and without a commercial agenda. Therefore, neither the concept of voluntary contribution, nor the search for consensus can be stripped from ISO standard development. While the IDMP-O could provide some acceleration, development will remain slow, thereby providing time to address the challenges posed by data quality and, in case of EU, complex political landscapes. The global interest in IDMP is increasing as is the perceived value of the standard, as demonstrated by industry applying the standard to boost digitalization. However, a blindingly successful use case to fuel global adoption is yet missing. Time will tell whether this could be the European Health Data Space.

Uncertainty is added to this complex field by the second Trump administration in the USA which has reduced US FDA’s engagement and has damaged a key player in IDMP by its withdrawal from WHO. These actions have left a gap in the global leadership for the implementation of IDMP. Hope lies in the growing interest for collaborating with Asian regulators, a development allowing for replacing the EU-US leadership by an EU-Asia alliance  which in turn could sustain the momentum toward a global implementation of IDMP.

Pages: 68 

Annexes: 1 Pages: 18