What lies ahead for IDMP?
The EU’s identification of medicinal products (IDMP) standards implementation was all set to go ahead, when the EMA suddenly announced a change of plan. The DADI user interface will now enable structured data submissions for the EMA PMS, at least for the near future. Drawing on recent dialogue with the EMA, Amy Williams, a Director at Iperion, addresses the known concerns of pharma companies.
The European Medicines Agency (EMA) is in the process of implementing the standards developed by the International Organization for Standardization (ISO) for the identification of medicinal products (IDMP). The IDMP standards specify standardised definitions for the identification and description of medicinal products and aim to facilitate the reliable exchange of medicinal product information, ensuring wide interoperability across global regulatory and healthcare communities.
Early this year, the EMA wrongfooted the market by announcing that, until further notice, the Digital Application Dataset Integration (DADI) user interface, which replaces the electronic Application Form (eAF), will now be the vehicle for structured data submissions for the EMA Product Management Service (PMS).
Go-live is in October 2022, but pharma companies now have until April 2023 to adapt their current compliance activities. There is a lot for them to think about, especially if they have already invested considerable resources and budget in preparing for IDMP Iteration 1 submissions.
Nevertheless, companies can take some clear next steps to realign themselves without compromising either their achievements thus far, or their wider ambitions.
First things first
If you are well into the implementation of IDMP or have a mature data management framework and established data submission processes, it may just be a case of confirming compliance and availability”
The EMA’s latest move means that both life sciences companies and their technology vendors need look at their immediate priorities. Full IDMP implementation will still take place eventually and therefore there needs to be a consideration for data initiatives. In fact, the go-live of DADI effectively accelerates the submission of structured PMS data.
Although the DADI interface only replaces the eAF, its nomination offers pharma organisations a chance to test out their PMS/data readiness.
Technology and software vendors will also need to readjust but, it really is just a question of refocusing, so existing investments will not go to waste.
Processes, organisation, technology and information
The new focus on DADI has an effect on every aspect of your current IDMP programmes.
If you are well into the implementation of IDMP or have a mature data management framework and established data submission processes, it may just be a case of confirming compliance and availability ready for the April 2023 deadline.
But for perhaps the majority, there are some key considerations for discussion.
DADI represents the first step towards realising the EMA Target Operating Model – tying the submission of data to the regulatory activities.
The transition to the DADI webform for the eAF provides companies with an opportunity to evaluate their processes, gaining insight on, for instance, who currently populates the eAF for submission. Addressing questions for DADI from an eAF perspective allows companies to meet immediate compliance needs without disrupting existing or ongoing IDMP preparations. A fuller overhaul can come later without having to rush the critical change management activities required for a successful adoption.
Organisation focuses primarily on data governance, training and change management, and here there are a number of factors to consider.
- Data governance. Heading towards IDMP, plenty of guidance has already been provided around Substance, Product, Organisation and Referential (SPOR) data specifications, and it makes sense to continue to lay the foundations of your data governance in line with these standards. This will serve not only IDMP Iteration 1, the US Food and Drug Administration (FDA)’s IDMP implementation but also DADI. You need to decide whether to extend your data governance framework to include the DADI fields, and if you want to focus only on the static data elements or also look to standardise the transactional data elements.
- Change management. Keeping everyone informed about the latest changes, the reasons behind them, and the short-, medium- and long-term implications will be important to maintain focus, engagement, morale and programme momentum. Inform all your stakeholders of the latest revisions to the plan and the impact on deliverables and timescales.
- Training. Timely and relevant training remains critical to ensure that everyone understands not just what has changed in relation to IDMP Iteration 1, but also where DADI comes into the picture, as well as what the latest developments mean for stakeholders. What are the impacts on them? In practice, what do they need to know?
Technology vendors and service providers have their own adjustments to make and will want to do everything they can to be ready to support their clients. One immediate challenge is establishing how best to track and manage data across three linked sets of requirements: xEVMPD, PMS and IDMP Iteration 1, each with its own level of granularity. It will take careful thought and close tracking to reduce duplication of effort and frustration.
Without the application programming interface (API) for DADI the reality is that some companies will lose automation capabilities for the population of eAF/DADI in the short-term, which also needs to be kept in mind for resource planning.
Given DADI-related requirements for submitting structured data, which span non-centralised procedures as well as centralised authorisation activities, companies will need to determine what additional data will now need to be collected, where it resides and how much is already tracked within a regulatory information management (RIM) system or structured format. A further consideration is when and how to factor in additional data fields that will be needed in upcoming phases.
Take a deep breath
These latest changes give the industry a chance to take stock, allowing organisations to assess their activities and work out how far they still have to go”
The sudden shift in requirements from the EMA might feel overwhelming in the short term, but you can keep moving forward by breaking down the challenge into more tangible and actionable decisions and plans.
For pharma companies that already have an IDMP project well underway, continuing with data remediation activity still makes sense, given the scale of transformation that is ultimately required.
For companies that are not as far along with their IDMP activities, redirecting their projects may be the best course of action, reframing them to incorporate the new DADI-related requirements at this stage and pushing Iteration 1 compliance to a later phase.
These latest changes give the industry a chance to take stock, allowing organisations to assess their activities and work out how far they still have to go. Companies that adapt to the new requirements while remaining true to their own operational ambitions will stand in good stead for the future.
About the author
Amy Williams, a Director at Iperion – a Deloitte business, has 15 years of experience in Life Sciences Regulatory Affairs, particularly in optimising regulatory information management systems (RIMs). Iperion, now part of Deloitte, is a globally operating life sciences consultancy firm.