Five Steps To Preparing For The Product Management Service (PMS) Of EMA's SPOR Program

The European Medicines Agency (EMA) is driving a major shift towards data standardization and digitalization with its Product Management Service (PMS) database, a core component of the SPOR program. This initiative aims to streamline regulatory processes and improve transparency across the EU. However, many companies are struggling to understand and meet the complex requirements of PMS, especially in light of the looming 2025 deadline for full SPOR compliance. Failure to prepare could hinder your ability to submit electronic applications, manage product information, and comply with critical medicine regulations.

This article provides a clear 5-step checklist to demystify the process and ensure your company is fully prepared for PMS, SPOR, and IDMP. Read on to learn how to navigate these critical changes and ensure your products remain compliant in the evolving European regulatory landscape.