Online event recording
Success for First-Time Drug Launches: How Early IDMP Adoption Reduces Risk & Accelerates Approval
28. July 2025
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For emerging biopharma companies bringing their first drug to market, navigating the EU regulatory landscape is complex.
Compliance with Identification of Medicinal Products (IDMP) standards is critical for a smooth submission and approval process - one that can make or break a successful launch.
The European Medicines Agency (EMA) requires strict adherence to IDMP standards, ensuring product data is structured, consistent, and interoperable. Early adoption of IDMP isn’t just about meeting compliance requirements, it’s about reducing the risk of regulatory delays, rejections, and data inconsistencies that could slow down approvals and disrupt market entry. Without a solid IDMP strategy, first-time launch companies risk delays, rejections, and compliance setbacks that could hinder market entry.
To avoid these roadblocks, early adoption of IDMP is a game-changer. By structuring product data in alignment with IDMP requirements, companies not only streamline their first EU submission but also set themselves up for long-term success. IDMP compliance improves data traceability, supports seamless pharmacovigilance, and simplifies future market expansions - both in Europe and globally.
Access our webinar to learn how our industry-leading approach can help you navigate regulatory challenges and position your first drug launch for success.
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