Commentary on the draft revised guideline on the environmental risk assessment of medicinal products for human use

Rhys Whomsley,Birger Scholz,Ines Roennefahrt,Caroline Moermond,Henry Stemplewski,Susanne Brendler-Schwaab,John Jensen,Laila Sortvik Nilssen,Eadaoin Griffin

doi:10.1186/s12302-019-0198-9

Abstract

Applicants for marketing authorisation for human medicinal products in the European Union must submit an environmental risk assessment which is assessed by assessors from the national competent authorities. The EMA guideline on the environmental risk assessment of medicinal products for human use came into effect on 1 December 2006. After 12 years’ experience with the guideline, the EMA has released for public consultation a draft revision of the guideline. The revision proposes significant substantive and structural changes to the guideline. The major changes proposed in the revision are outlined together with the rationale for the changes and the expected impact on stakeholders.

Highlights

The European Medicines Agency (EMA) has released for public consultation a draft revision of the guideline on the environmental risk assessment (ERA) of medicinal products for human use [1]
The current version of the guideline [2], which came into effect on 1st June 2006, describes how the ERA should be performed by applicants during the application for marketing authorization of human medicinal products (HMP), a risk to the environment cannot be considered as a criterion to refuse a marketing authorisation
In 2016, the EMA published for public consultation a concept paper [4] in support of the revision of the guideline which documented 8 proposed issues for revision, including the tiered approach strategy and relevant triggers for progressing through the tiers, better utilization of publicly available data, assessment approaches for PBT substances and endocrine disruptors, updates on test systems/assays and options for risk mitigation measures

Summary

Introduction

Background The European Medicines Agency (EMA) has released for public consultation a draft revision of the guideline on the environmental risk assessment (ERA) of medicinal products for human use [1]. The current version of the guideline [2], which came into effect on 1st June 2006, describes how the ERA should be performed by applicants during the application for marketing authorization of human medicinal products (HMP), a risk to the environment cannot be considered as a criterion to refuse a marketing authorisation.

Results

Conclusion