02.06.2020 | LOGFILE Feature 22/2020

Excerpt from our Guideline Evaluation of the environmental risks of medicinal products: ERA reports

Environmental Risk Assessment: ERA Reports

8 min. reading time


1 Introduction: environmental risk evaluation

Due to the increased levels of active pharmaceutical ingredients (APIs) in surface water and groundwater, soil, air, and biota, there is a need to assess their impact on organisms in the natural environment.

This guide aims to describe the evaluation of the potential environmental risks of medicinal products for human use. In addition, it includes considerations about possible precautions and safety measures to be taken, as well as a set of recommendations. Environmental Risk Evaluation (ERA) refers to risks related to the use, storage, and disposal of medicinal products and not to any risks resulting from the synthesis or manufacture of these product

2 Regulations

Based on the knowledge that APIs can pose an environmental risk and, in accordance with the provisions of Article 8(3) of Directive 2001/83/EC of the European Parliament on Medicinal Products for Human Use, the EMA (European Medicines Agency) published a guide that came into effect in 2006 (EMEA/CHMP/SWP/4447/00).

Furthermore, the German Federal Environmental Agency (UBA), one of the most prominent and active authorities in the field, evaluated a total of 120 environmental risk evaluations (ERA) in the years 2006-2014. Approximately 10% of the ERAs concluded that the pharmaceutical  substance in question supposed an environmental risk.

Since the EMA guide came into effect, several subsequent changes have been made to the initial version. Furthermore, a Q&A document published in 2011 has been recently updated in order to clarify certain aspects of implementation of the guide.

Finally, a document published more recently by the EMA (EMA/CHMP/ SWP/65429/2016) presents a review of the environmental risk evaluation guide for medicinal products of human use (EMEA/CHMP/SWP/4447/00 corr 2) based on the latest available scientific knowledge. This review  aims to provide a set of harmonised requirements for the ERA based on current scientific knowledge, as well as to optimise the tiered approach.

3 Evaluation Phases

The ERA employs a gradual approach consisting of two separate phases:

You get the entire guideline here for free.

Toxicological Assessments

Toxicological Assessments

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  • PDE – Permitted Daily Exposure value reports 
  • Elemental Impurities Risk Assessments (ICH Q3D)
    OEL – Occupational Exposure Limit categorisation
  • ERA – Environmental Risk Assessment
  • Organic Impurities (ICH Q3A und ICH Q3B)
  • Mutagenic Impurities (ICH M7)

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