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After years of preparationand discussion, the pharmaceutical industry is finally gearing up for the rollout of IDMP (Identification of Medicinal Products). The European Union will be the first to adopt these regulatory standards in 2023, with other regions expected to follow shortly after.
IDMP will require pharmaceutical companies to report data to support a more evidence-based regulatory system for managing medicinal products. The framework creates a standard identification system for medicinal products across contract research organizations (CROs), biopharmaceuticals, global regulators, and other life science organizations.
As IDMP continues to evolve, here are three critical steps life science organizations can take toward a full-proof strategy that supports changing regulatory requirements.
In order to meet IDMP requirements, companies are scrambling to update systems to prepare for the change. Closed communication systems are now being exposed, and data silos are being targeted with new information-sharing solutions.
However, retroactively imposing systems can be just as damaging as a data silo. Instead of looking for an IDMP solution that fits the whole organization, many organizations are piecing together different tools for a short-term fix. Ultimately, this requires employees to understand multiple data management tools and the nuances of each system. A confusing combination of solutions can make a system just as prone to misreporting—which is precisely what IDMP was created to solve.
Because IDMP’s regulatory requirements have implications throughout multiple domains, finding a system that allows for communication across teams makes a significant difference in meeting cross-functional goals. The first step is identifying a compatible open application programming interface (API) that enables data to be shared across the organization and offers a solution that is already optimized for the whole organization, not just for a specific team.
With a stand-alone IDMP solution, pharmaceutical companies can avoid the complications and expenses of having multiple vendors for the same solution. Instead of piecemealing a solution, finding a universal tool can be more impactful and effective.
Pre-IDMP, pharmaceutical organizations were allowed individual preferences in collecting data, which meant different standards for naming and recording. In some instances, this looked like manual processes or slight differences in data records across organizational teams.
With new data-based regulatory requirements coming, the margin for error in reporting will narrow. Automated reporting systems can cut down on spelling errors, missing content, correct medicinal naming, and so on. These touchpoints seem small, but they save valuable time and energy when compliance teams pass IDMP standards. Re-submitting data and correcting slight issues in reports can be time-consuming and a waste of resources when automation could have prevented these minor errors.
Artificial intelligence (AI) has been evolving in all industries, and the pharmaceutical industry is no exception. In terms of IDMP preparation, companies are starting to consider how AI can fit into the data management solution. For some, handing over data to an automated or AI system can seem like a risk. In reality, AI frees up human capital for higher-value initiatives by handling repetitive, menial tasks.
Automation systems also require companies to formalize their internal regulatory processes, leading to considerations of best practices for data collection. The time-saving results of automation paired with revamped, updated methods can have twice the impact on pharmaceutical companies’ efficiencies.
Like with any regulatory standard, it’s not enough to make a plan for the current IDMP standards. Organizations need to have an eye on what’s next. Compliance expectations typically change year-to-year, so it is critical to identify a digital tool that supports evolving IDMP regulatory standards.
Pharmaceutical companies benefit from agile systems. They have measures in place to seamlessly transfer previously stored data as reporting standards change. An IDMP solution with rolling cloud updates ensures that previously stored data automatically updates for upcoming reports as these new compliance standards are released.
Ideally, the IDMP data compliance tool selected also serves pharmaceutical companies’ other compliance needs like xEVMPD, UDI and SCL. Again, finding a system that benefits the whole organization instead of a narrow subset will contribute to efficiency and relieve workloads for employees so organizations can focus on innovating and improving their products.
The European Union’s adoption of IDMP compliance is just the start of a wave that will eventually impact other International Organization for Standardization (ISO) countries. As companies expand into other regions, being IDMP compliant can put them ahead of their competitors and remove barriers to entering these new markets.
Beyond the logistical benefits of adopting IDMP standards, the pharmaceutical products impacted by these compliance initiatives serve health communities and make meaningful impacts. Freeing up resources to focus on these community health goals should be every pharmaceutical company’s priority. Choosing the right reporting tool can make a difference that changes someone’s life.
Life science organizations are better off finding a solution that sets them up for long-term compliance instead of pivoting or re-tooling their current systems as regulatory requirements change. Looking ahead to what the pharmaceutical market holds, taking proactive steps towards future-proofing organizations is a simple but powerful way to elevate the life science industry.
Robin Schilling is Global Product Manager, IDMP, at ArisGlobal.