28.04.2020 | LOGFILE Leitartikel 17/2020

Auszug aus unserer Guideline Evaluation of the environmental risks of medicinal products: ERA reports

Umweltrisikobewertung für Humanarzneimittel

8 Min. Lesezeit


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:

Die gesamte Guideline bekommen Sie hier kostenlos als PDF-Download.


Toxikologische Gutachten

Toxikologische Gutachten

Befassen Sie sich mit den wirklich wichtigen Dingen in Ihrem Pharma-Alltag. Wir erstellen Ihre regulatorisch geforderten toxikologischen Gutachten – Sie sparen Zeit und Ressourcen!

Wir unterstützen Sie mit diesen Gutachten:

  • PDE – Permitted Daily Exposure value reports
    PDE-Gutachten für Wirkstoffe
  • Elemental Impurities Risk Assessments (ICH Q3D)
    Toxikologische Bewertung von elementaren Verunreinigungen
  • OEL – Occupational Exposure Limit categorisation
    OEL-Kategorisierung für Wirkstoffe
  • ERA – Environmental Risk Assessment
    Umweltrisikobewertung von Humanarzneimitteln
  • Organic Impurities (ICH Q3A und ICH Q3B)
    Toxikologische Bewertung von organischen Verunreinigungen
  • Mutagenic Impurities (ICH M7)
    Toxikologische Bewertung von mutagenen Verunreinigungen

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