After more than 10 years of preparation, the new Identification of Medicinal Products (IDMP) standard is set to go live in 2023. IDMP facilitates the unique identification of medicinal products in an effort to promote global harmonization of data, leading to safer products, fewer drug shortages, and a streamlined, global exchange of information.
To prepare for the 2023 IDMP launch, life science organizations should finalize their plans for complying with the International Organization for Standardization (ISO)’s new standard. European-based companies and organizations that distribute medicinal products to the EU will be affected first.
While the European Medicines Agency (EMA) is the first to pioneer the adoption of IDMP, other ISO countries will likely follow suit. In other words, all pharmaceutical companies should prepare for the new IDMP standards. After all, stopgap solutions that translate and transcribe regulatory submissions without standardizing referentials across the drug development lifecycle will become inadequate.
But buyer beware: Most IDMP solutions on the market today are immature and offer basic data translation capabilities that work only within regulatory systems — rather than across each arm of a company. Instead of Band-Aid solutions, life science organizations should invest in a long-term IDMP software solution that provides efficiency, agility, and sustainability as the regulatory landscape changes.
Here are three ways a long-term software solution helps ensure a foolproof IDMP strategy.
1. Clear, cross-functional hurdles
Data is the lifeblood of life science’s digital transformation. Drug developers need to synchronize their data across the drug development lifecycle — including clinical, safety, medical affairs, and regulatory. This task is one of the most significant challenges facing life science organizations preparing for IDMP because standards apply to everything from dosage forms to units of measurement to packing.
Since teams store data in multiple locations across an organization, they need an IDMP software solution to integrate and communicate with all business-critical systems in advance of the EU deadline. Without open communication, regulatory teams would have to manually transfer information, resulting in errors, wasted time, and decreased productivity. Those negative impacts delay approval times and eat away at drug development’s waning profitability.
So what is the solution to clearing cross-functional hurdles? An open application programming interface (API). Solutions with an open API seamlessly share data with any other technology — regardless of whether those systems usually share data. Open architecture IDMP software acts as a bridge between various platforms, from Clinical Trial Management Systems (CTMS) to Safety and Regulatory Information Management Systems (RIMS).
Alternatively, closed-system solutions require add-on services to facilitate data sharing and can only pull from associated technologies — which is not ideal, especially while preparing for IDMP.
No company purposefully purchases closed-system solutions, but sometimes they get stuck with one. Why? Because some vendors over-promise and under-deliver by selling on the software’s future state, not its current state. Consequently, life science companies end up purchasing a vision and not an actual product. Workarounds for closed-system solutions exist but cost extra and aren’t always user-friendly.
Standalone IDMP solutions with an open API can quickly bring organizations up to speed while providing a long-term solution that doesn’t need a complete technological overhaul.
2. Reduce errors and increase efficiency
How an organization names documents, collects and stores data, and communicates information needs to be translated to IDMP standards. The best way to do that? Process automation — a review once, use often approach.
More than 80% of the life sciences community uses automation across its research and development (R&D) processes. As organizations adopt new data-based regulatory requirements, the margin of error in reporting will narrow.
Automation helps cut down on errors like spelling mistakes and missing content and corrects medicinal naming by proofreading submissions and checking for IDMP compliance before sending submissions to regulators. This saves time and money as correcting report issues and resubmitting data burns resources. Each department, like regulatory, clinical, safety, quality, and manufacturing, must have the exact same naming conventions. If any department uses different terminology, the reporting will get kicked back to the company.
Handing over data to an automated system frees employees to focus on higher-quality initiatives because the machine handles manual, repetitive tasks. Automated systems also require companies to formalize their internal regulatory processes, leading to considerations of best practices for data collection and a quicker approval process.
3. Future-proof compliance
Only cloud-based IDMP solutions can keep up with an ever-changing industry. As more countries adopt IDMP, submissions will need to meet these standards in addition to standards unique to individual regions.
A technology vendor will be able to push continuous updates to a cloud-based system while it’s in use. Continuous updates also need an open API. If IDMP software can connect to all systems under an organization, it will keep each system compliant with evolving IDMP regulatory standards.
For example, a closed system associated with RIMS may keep regulatory teams up-to-date but risk teams falling behind. A system with open API benefits the whole organization, increasing efficiency and reprioritizing workloads for employees so they can focus on product innovation and community health goals.
IDMP compliance will be mandatory for organizations with a European presence next year, but eventually, more ISO countries will adopt the standard. Additionally, organizations with growth ambitions may operate in regions that will use IDMP in the future. Preparing now sets these organizations up for success and keeps them from scrambling to find a solution later.
Employing automation will facilitate a smoother transition and ensure all submissions comply with various standards. Taking proactive steps and planning years — not just months — ahead offers a proactive, powerful strategy to ensure IDMP compliance and elevate organizations within the life science industry.
About Author
Robin Schilling, Global Product Manager, IDMP, ArisGlobal
