19 March, 2025

NERD Project and Its Importance

Insights Hub

The pharmaceutical regulatory landscape is evolving rapidly, and 2025 is shaping up to be a busy year for pharmacovigilance (PV) in the European Union. With significant changes on the horizon, staying ahead of regulatory updates is critical for pharmaceutical companies to maintain compliance and ensure patient safety.

At PrimeVigilance, we are committed to providing industry-leading expertise and proactive regulatory intelligence. Our New European Regulation Development (NERD) Project is designed to help organizations navigate the complexities of evolving PV regulations, ensuring they remain compliant and well-prepared for upcoming changes.

One of the most notable developments is the anticipated update to Implementing Regulation (EU) 520/2012, along with corresponding revisions to several Good Pharmacovigilance Practice (GVP) Modules to align with the evolving regulatory landscape. Additionally, the European Medicines Agency (EMA) is working to finalize and publish updates to other GVP modules, addendums, and Product- or Population-Specific Considerations.

Recognizing the dynamic nature of these changes, PrimeVigilance has launched the NERD Project, led by a dedicated team of subject matter experts (SMEs) from the Medical Scientific Affairs and Regulatory Intelligence and Analytics departments. This initiative provides early insights, in-depth analysis, and timely implementation strategies to ensure companies are well-informed and ready to adapt.

For all new EMA guidelines open for public consultation, NERD proactively reviews and, where applicable, contributes by proposing best practices learned from years of practical experience.

As part of this initiative, PrimeVigilance will publish a series of articles breaking down regulatory updates and their implications.

How PrimeVigilance Can Help

Navigating regulatory changes can be complex, but staying compliant is critical. PrimeVigilance’s team of pharmacovigilance experts is at the forefront of global regulatory updates, ensuring that our partners remain aligned with evolving legislation. Through our NERD Project, we provide early insights, strategic recommendations, and compliance solutions that ensure your organization remains at the forefront of regulatory developments.

Stay ahead of regulatory changes with confidence—contact PrimeVigilance today to discuss how we can support your organization’s pharmacovigilance needs.