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The EMA has published a revision to its guideline on the environmental risk assessment of human medicines.
The European Medicines Agency (EMA) has published a revision to its guideline on the environmental risk assessment (ERA) of human medicines, which is now open to comments from stakeholders for a six-month period, it revealed in a Nov. 30, 2018 press statement.
This revision introduces a decision tree, which is aimed at clarifying when ERA studies are necessary. Additionally, the decision tree will provide more detailed technical guidance to those companies looking to submit a marketing authorization application for a medicine to better the consistency of assessments.
Furthermore, the proposed revision has introduced the term ‘endocrine active substances’, which will include all compounds that have an effect on the development or reproduction of biological species. In relation to this, there will also be guidance provided on how the level of indirect exposure of pharmaceuticals (secondary poisoning via the food chain) can be estimated.
There is also a proposal to limit the use of a laboratory test method within the revision, which will reduce the burden of testing on those applying for marketing authorization of a medicine. The test highlighted in the revision is the Organization for Economic Co-operation and Development 308 environmental fate test.
This revised guideline, published 12 years after the original, has been based on a concept paper that was issued in 2014 along with work from a group of experts that were led by the Safety Working Party from EMA’s human medicines committee.