IDMP Still Holds Business Value, in spite of EMA Delays
Earlier this year, EMA announced delays in the implementation and enforcement of the of IDMP standards to beyond 2020, due in part to Brexit and the EMA headquarter relocation. EMA also delayed progress on the controlled vocabularies program for Referential Management Services (RMS) and Organizational Management Resources (OMS).
Following this announcement, IRISS surveyed the industry to gauge the impact of further delays. Some interesting observations emerged:
- Most respondents are optimistic that the IDMP and Substances, Products, Organisations and Referentials (SPOR) initiatives still hold business value. Additionally, most companies (59%) with an IDMP/SPOR program are proceeding, despite the deadline delay and lack of clear guidelines from EMA. However, about one-third of respondents put their program on hold, awaiting the publication of the EU implementation guidelines and an EMA revised plan. Less than 10% of respondents have closed or reduced the scope of their projects.
- The delayed EMA guidance is having a greater impact on plans for internal process changes to support SPOR and IDMP compliance. A minority will proceed as planned, while 24% will put process changes on hold. Many of those indicating there will be “some impact” will narrow their focus to those process improvements with internal business value, whereby IDMP compliance becomes a side benefit.
- How to access and consume the EMA master data management services is a key area of focus for respondents. Access through the web UI is preferred over using the API (application programming interface). Plans for consuming the Organizations and Referentials data varies broadly, as about 30% of respondents will align these terms with all internal systems. Another one-third will align the terms with only regulatory systems. The remaining respondents will align the data fields on a case-by-case basis.
- The technical approach to managing IDMP data varies: 43% of the respondents plan to use a separate IDMP hub with data feeds to and from other systems, 20% will manage IDMP data within their RIM system, and 26% have yet to decide.
- Most RIM system initiatives will proceed despite the delays: 29% will continue even though related to IDMP/SPOR, 29% will continue decoupled from IDMP/SPOR dependencies, and 17% will continue as they had no relation to IDMP/SPOR. Similarly, most initiatives around Falsified Medicines Directive (FMD) will proceed, with 31% decoupling their FMD initiative from IDMP/SPOR dependencies.
From the IRISS survey results, it is evident that industry still supports IDMP/SPOR initiatives. However, requirements and specifications from the EMA are critical to ensuring success.