Regulatory Changes on the Horizon: Global Impact of the IDMP
Pharmaceutical manufacturers and CROs face increasingly complex regulatory mandates on the horizon. As requirements increase, so do opportunities for problems with lack of compliance and inconsistent data. To this end, the European Union (EU) is adopting a standard protocol for Identification of Medicinal Products (IDMP) developed by the International Organization for Standardization (ISO).
The Move Toward IDMP
IDMP seeks to inventory authorized medicines and deliver structured, quality-assured information. This regulation supports EU terminology for products, substances, and organizations in order to power pharmacovigilance and regulatory systems. In this, they hope to improve safety signal detection and response, verify authenticity, address shortages and recalls quickly, and increase regulatory efficiency. This transition is part of a two-year rollout with adoption mandatory by 2018.
The IDMP data model defines elements, structures, and vocabularies based on five ISO standards. These describe a product and its components—including identifiers for traceability through registration, manufacturing, and packaging. The database includes information according to the EU Telematics Data Management Model of substances, products, organizations, referentials, and timeframe.
Under IDMP, labeling information and other data moves into repositories. Changes required by IDMP will influence labeling, submission, and data-management practices. Current Structured Product Labeling (SPL) in the US cannot carry to the EU because of the documents, data, timescales, and languages involved. Structured Content Authoring (SCA) will grow for new labels—and extraction tools will improve for older ones. In addition, US SPL relies far too much on manual entry, outsourcing, suffers from a lack of data control or linkage, and allows for potential compliance issues.
For life-science organizations maintaining documentation in Word, IDMP standardization presents several compelling reasons to move toward XML. XML is more flexible and better equipped to drive efficiencies—including time and resources devoted to changes such as dosage and versioning. Document management systems like Documentum—our organization’s preferred platform—allow users to control information from a central repository. The advantages become apparent the moment a pharma manufacturer must implement content changes that potentially affect hundreds of product information documents and data points.
The Bottom Line
As the EU—followed closely by FDA and other regulators—moves to adopt IDMP, standardization requirements will grow. This means pharma companies must invest in IDMP. As always, it is best to be ahead of the curve. Fortunately, the fact that we can see this change on the horizon gives us ample time to prepare—provided we do so correctly. Look for additional insights on how the move toward IDMP can potentially affect labeling, submission, and data-management practices in later posts.
As CEO of Glemser Technologies, I lead a team of life science compliance IT professionals to deliver solutions for Content Management and Quality Management. In future installments, I will share additional insights and case studies that support the strategies and implementations of these topics.