Primary source: Download medicine data | European Medicines Agency (EMA)
The introduction of a reliance-based pathway allows non-EU regulators to utilize EMA's safety evaluations for faster global safety communication and label updates.
This change accelerates the implementation of safety-related updates across multiple jurisdictions, promoting consistent risk communication, and significantly reducing the time to update safety labels globally.
Pharmaceutical companies wishing to participate in the pilot must submit the same documentation to all involved national authorities, thus standardizing the submission process.
Regulatory Intelligence Lead
Review before 2026-08-13.
Introduction of a reliance-based pathway for post-authorisation variations; use of EMA assessment reports by participating non-EU regulators; pilot program procedures for simultaneous submission and shared assessment results.
This change facilitates the faster global implementation of safety-related updates to product information. By allowing non-EU regulators to rely on EMA's safety evaluations, it ensures more rapid and consistent risk communication and mitigation across multiple jurisdictions, reducing the time to update safety labels globally.
Pharmaceutical companies wishing to participate in the pilot must submit the same documentation to all involved national authorities, thus standardizing the submission process.
The European Medicines Agency (EMA) has published new guidance on a pilot program for a reliance model for post-authorisation changes (variations). This program permits pharmaceutical companies to leverage EMA assessment reports to support simultaneous submissions to regulatory authorities outside the EU, thus streamlining the approval process for safety-related updates.
What changed: The introduction of a reliance-based pathway allows non-EU regulators to utilize EMA's safety evaluations for faster global safety communication and label updates.
Why it matters: This change accelerates the implementation of safety-related updates across multiple jurisdictions, promoting consistent risk communication, and significantly reducing the time to update safety labels globally.
Practical implication: Pharmaceutical companies wishing to participate in the pilot must submit the same documentation to all involved national authorities, thus standardizing the submission process.
Published from the Firecrawl policy change extraction pipeline.
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