When selecting an IDMP solution, remember decisions made today will impact the organization for years to come
After a decade of preparation, the new Identification of Medicinal Products (IDMP) standard is poised to go into effect in a few short months. The impending change is forcing life science organizations, many of which put planning efforts on pause amid rollout delays, to quickly finalize their plans for complying with the new standard.
Developed by the International Organization for Standardization (ISO), IDMP aims to improve product and patient safety by using a standard identification system for medicinal products across Contract Resource Organizations (CROs), biopharmas, global regulators, and other life science organizations. The European Union is pioneering adoption of IDMP beginning in 2023, affecting not only European-based organizations, but also any organization that distributes medicinal products within the EU. The EU in only the first to move forward with IDMP – other ISO countries are expected to adopt the standard in the future as well.
The effects of IDMP will evolve as new regulatory bodies adopt the standard and as clinical development organizations expand into new markets where IDMP is already implemented. Stopgap solutions that translate and transcribe regulatory submissions without standardizing referentials across the drug development lifecycle will quickly become insufficient. In other words, leaving the Regulatory team to bring submissions up to IDMP standards at the last moment may work for a while, but will soon become overwhelming. Life science organizations would be better off investing in a long-term solution that will provide more efficiency and agility over time, as the regulatory landscape changes.
Most technology vendors are still building IDMP solutions. Of those on the market today, most are immature, offering rudimentary data translation capabilities that work only within regulatory systems, rather than across each arm of the company. Long-term IDMP software solutions will need to standardize referentials across the drug development lifecycle, from discovery to post-marketing authorization.
Open architecture and interoperability is key to clearing cross-functional hurdles
The greatest challenge facing organizations preparing for IDMP is integrating structured data across domains, from Clinical to Safety, to Medical Affairs and, of course, Regulatory teams. Since IDMP standards apply to everything from dosage forms to units of measurement to packaging, drug developers will need to reconcile their data across the organization.
Disjointed technology systems will thwart this effort. Many organizations use disparate technology vendors and solutions within each business function, which is why it’s critical that your IDMP solution can integrate and communicate with all business-critical systems. Without this open communication, Regulatory teams will be forced to manually transfer information. The result? Errors, wasted time, and decreased productivity – all of which eat away at the waning profitability of drug development.
Easy integration begins with an open API to seamlessly incorporate technology within your organizational stack. Solutions with an open API render the technology entirely agnostic, meaning it can seamlessly share data with any other technology. Think of it as a universal plugin that is compatible with all existing systems, regardless of whether those systems can normally share data. Open-architecture IDMP software acts as a bridge between various software platforms, from Safety to Clinical Trial Management Systems (CTMS) and Regulatory Information Management Systems (RIMS).
The value of an open API becomes even more evident when considering the alternative. Closed-system solutions require proprietary add-on services to facilitate data sharing across different systems. Rather than open lines of communication across the various arms of the organization, these closed-system solutions can pull only from associated technologies. Workarounds exist for an additional cost but are often less user-friendly.
Standalone IDMP solutions are best equipped to bring organizations up to speed quickly while providing a long-term solution that doesn’t require a complete technological overhaul.
Automation capabilities reduce errors and increase efficiency
Every organization has its own unique conventions for naming documents, collecting and storing data, and communicating information, all of which will need to be translated to IDMP standards. By hand, this task is cumbersome, time-consuming, and involves a greater risk of costly errors.
Process automation is the best solution. The use cases for such automation go further than IDMP – it can be used to auto-translate data based on individual regulatory bodies’ requirements as well, efficiently and accurately preparing submissions for every region an organization works within.
Further down the line, automation can be used as a proofreader, scanning submissions for errors and IDMP compliance before they are sent to regulators, ultimately enabling the organization to avoid findings that can delay approvals.
As these solutions mature technologically, there is an opportunity for vendors who have invested in advanced automation to introduce AI-driven automation capabilities. For example, consider the benefits of introducing Natural Language Processing to automatically produce Subjective Narratives. Such features, once available, would free employees to focus on high-value initiatives while the machine does the manual or mindless tasks that take up so much time today.
Future-proof compliance with rolling cloud updates
Given the lengthy rollout of IDMP standards – with more releases from the ISO and EMA due in a few months – existing IDMP solutions will need to be agile enough to adapt to regulatory changes before and after the standards go into effect next year. This will also be critical as more countries adopt IDMP, as submissions will need to meet IDMP standards in addition to those that are unique to those individual regions.
As such, IDMP solutions will have to be cloud-based to keep up – this will enable the technology vendor to push continuous updates to the system while it’s in use. These updates represent another reason that the IDMP solution should have an open API. If the IDMP software can connect all the disparate systems under one organization, it will be able to keep each system compliant, even as things change. A closed system associated with the RIMS may keep Regulatory teams up-to-date but risk the other areas falling behind.
Naturally, any IDMP solution should also encompass other standards like xEVMPD, UDI, SCL, etc. The system itself should be prepared for all compliance standards, rather than an add-on specifically for IDMP.
Think years ahead, not months
While IDMP compliance will be compulsory for organizations with a European presence next year, the change won’t stop there. More ISO countries will eventually adopt the standard. Plus, organizations with ambitions to grow might not operate in regions that use IDMP now, but may in the future. Preparing now will set these organizations up for success and keep them from scrambling to find a solution later.
An appropriately well-rounded IDMP solution will keep all domains compliant through an open API that bridges disparate software and will be prepared to adapt swiftly to IDMP modifications or adoption by new regulators. Automation will go a long way toward making this transition smooth and ensuring all submissions comply with a host of standards, from IDMP to xEVMPD.
Life science organizations must invest now in a solution that will keep them compliant today and tomorrow. Stopgaps may be a cheaper short-term fix, but will ultimately become insufficient.