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Pharma Talks - ERA of Human Medicinal Products

25th April 2025

Environmental Risk Assessment of Human Medicinal Products – What Has Changed?

In a recent webinar hosted by Chemsafe Srl, Dr. Antonio Conto provided a detailed retrospective on the evolution of the Environmental Risk Assessment (ERA) for human medicinal products over the past 18 years. His presentation highlighted the key regulatory and scientific developments leading up to the implementation of the new EMA guideline, which officially came into effect on September 1, 2024.

Dr. Conto emphasized the growing importance of ERA in ensuring the environmental safety of pharmaceuticals and outlined how the updated guideline introduces more comprehensive and demanding requirements for risk evaluation.

At ibacon, we support pharmaceutical companies in navigating these new expectations with tailored, end-to-end solutions. Our scientific and regulatory expertise ensures your ERA submissions meet the current standards with confidence.

The presentation summarizing these updates is now available for download.