IDMP Update 2017 / 2018 – Moving forward bit by bit
Though no binding specifications have been issued by the European Medicines Agency (EMA) for when the IDMP (Identification of Medicinal Products) regulation has to be implemented, quite a bit has happened in the area over the past few months.
This IDMP Update article summarizes the most important events from 2017 / Q1 of 2018 pertaining to IDMP. It also provides insight into the mood in the industry based on current project experiences and our customer network, as well as the results of our online survey on IDMP readiness.
Milestones from 2017 to today
June 2017 – Go-live of OMS / RMS
In June, the SPOR systems OMS (Organizational Management System) and RMS (Referential Management System) went live: in implementing IDMP, the two EMA systems and their corresponding master data are necessary to roll out the PMS and SMS SPOR systems (Product Management Systems, Substance Management Systems), which are also planned.
Designated data stewards manage the SPOR OMS / RMS, supplement data and are the point of contact whenever stakeholders have questions. National drug authorities (NCA) have had access to these systems since they went live, supporting the EMA in maintaining and supplementing OMS / RMS data (controlled vocabularies).
October 2017 – IDMP Update on ISO standards released
The two ISO IDMP standards Packaged Medicinal Products (ISO 11615) and Pharmaceutical Product (ISO 11616) were appealed and finally published in October, together with the corresponding technical specifications. The content of the standard remained the same, but some detailed information was removed and relocated to the associated technical specification. The standards now have a better structure, making them easier to read. You will find the current version of the ISO IDMP standards here.
(click the image to enlarge)
November 2017 – “…and the EMA goes to: Amsterdam”
The “Brexit” vote in 2016 has made it necessary for the EMA to leave Great Britain. In November, the decision was made to relocate the agency’s headquarters to Amsterdam, putting to end the game of tug-of-war for the new home of the EMA.
The move is set for completion by the end of March 2019, with the EMA and Dutch authorities aiming to make the transitional period as smooth as possible.
Thanks to the good connection and relative proximity to London, the agency expects the majority of staff will be willing to move or commute between London and Amsterdam.
As for the effects of the relocation on IDMP, the EMA knowingly extended the timeline as early as spring 2017, meaning IDMP is not expected to be officially introduced until 2020 or later.
December 2017 – OMS / RMS industry onboarding & gradual application
As of December 2017, industrial companies are required to register “super users” in the OMS/RMS systems. For this reason, the EMA has published an Industry Onboarding Plan. Starting in the first quarter of 2018, companies can register and manage additional users. Registered users are tasked with checking and maintaining OMS data, mapping referential data with controlled vocabularies and submitting any necessary change requests.
This data is accessed via a web portal with search, view and export functions. In addition, program interfaces (APIs) are available for data exchange. Though the EMA postponed the IDMP roll-out, IDMP data is now being gradually integrated into processes and activities relevant for marketing authorization.
Since December 2017, OMS data can also be applied in the four electronic submission forms (Marketing Authorization Application (veterinary and human), Renewals, Variations (post-approval changes)) – for now, optionally. However, OMS and the associated processes are expected to become mandatory in quarter three or four of 2018, meaning it is a good idea to get acquainted with OMS processes for supplementing or adding missing organizational data and the functions in eAF now (Referential and Organization Data in eAF
Besides the eAF, the new EU Clinical Trials Portal for registering clinical studies as well as the European Medicines Verification System, implemented as part of the Falsified Medicines Directive, will also be integrated along with RMS and OMS. Here, you will find the delivery time frame for the EU portal and EU database.
Mood and implementation strategies in the industry
On the EMA side, the implementation of IDMP is coming along pragmatically, but steadily. To what extent are industrial companies dealing with the topic? Last year, ARCONDIS observed very differing situations among customers in the industry when it comes to the focus and prioritization of IDMP activities.
While the major players in the pharma industry are driving forward IDMP applying a holistic approach with master data management initiatives, we have noticed that smaller companies tend to take a more reserved approach. The costs and advantages of IDMP activities are carefully considered, with a focus placed on meeting mandatory compliance requirements.
Strategies for IDMP implementation (click the image to enlarge)
The results of our study on the topic of IDMP Readiness 2017, which ARCONDIS carried out last year, surveying small to medium-sized companies (SMEs), attest to this. Nearly 40% of surveyed companies still haven’t initiated any IDMP projects, and one-fourth have put their IDMP initiatives on the back burner.
Insufficient information management and a lack of concrete requirements on the part of the EMA, as well as repeated delays to the timeline have resulted in major uncertainty. Respondents indicated that they do not yet feel adequately acquainted with the IDMP regulations and requirements.
After the EMA delayed once again, the topic has simply lost ground among senior management. Only 25% of respondents estimated the importance of IDMP among senior management to be either very or extremely important.
In addition to the delays of IDMP and a lacking EMA Implementation Guide, companies consider the following to be the greatest challenges:
- Availability and quality of IDMP-relevant data
- Data integration and the associated system and process adaptations
- Limited staff capacity
- Adaptation of the current systems and processes too costly
Recommended action: Take it step by step
In our opinion, a pragmatic approach of the EMA to gradually integrate IDMP into different areas can make for success at the EMA and among companies.
This way, SMEs can also be introduced to the topic step by step instead of being left to the wayside when the major SPOR systems SMS (Substance Management System) and PMS (Product Management System) return to the spotlight once the EMA headquarters relocation is complete.
For this reason, we recommend our customers to familiarize themselves with the RMS and OMS EMA systems and amended data management processes. Registering super users, as well as verifying and mapping data and its application in initial areas (e.g. eAF), is a very important starting point.
As for introducing the SMS PMS SPOR systems, manufacturers can benefit from performing a high-level gap analysis for their product data now with the aim to localize relevant data, making best use of the time available until the PMS and SMS roll-out, while identifying the major weak points. Companies can then derive and prioritize concrete actions based on the associated risks.