On March 21st 2024, the Nonclinical Working Party adopted the first revision of the Guideline on the environmental risk assessment of medicinal products for human use (EMEA/CHMP/SWP/4447/00 Rev. 1) that will come into force as of September 1st 2024.

This revision is the final result of a Concept Paper, published back in 2016.

The Environmental Risk Assessment (ERA) is an independent assessment of environmental and health risks, associated with exposure to contaminants, which includes medicinal products. The process involves a comprehensive scientific review of studies and identification and quantification of adverse effects that a pharmaceutical product might have on the ecosystem. The key elements of ERA include toxicological testing, biodegradability assessment and the evaluation of biopersistence.

The document provides guidance on how to prepare an ERA and assess potential environmental concerns, associated with the use of a certain pharmaceutical product. Moreover, the Guideline explains how to report potential findings and how to set precautionary measures based on risk assessment.

The revised Guideline gives more attention to certain types of chemicals, especially endocrine disruptors and PBT/vPvB (Persistent, Bioaccumulative, Toxic/very Persistent very Bioaccumulative) substances. Both risk and hazard assessments are now required. The assessment for such chemicals must be carried out irrespective of the safe threshold of the first calculated PEC (Predicted Environmental Concentration).

The Guideline also recommends a new tiered approach to risk assessment, imposes the use of actual consumption data, updates the classification of substances and provides guidance on the recommended test systems to be used.

This more scientific approach requires the experts to use a more comprehensive and robust scientific evaluation method.

An ERA is now required for all initial marketing authorization applications, regardless of the legal basis. It is also required for certain post-authorization applications, such as extension applications.

Our experts at Billev Pharma East can assist you with the preparation of an ERA for any type of substance and any type of application. Do not hesitate to contact us.