November 20, 2024 by Becky Brown
New guidance for the European Medicine Agencies (EMA) pharmaceutical environmental risk assessment (ERA) were published in February 2024, effective from September 2024. The new ERA guidance leads to many more Active Pharmaceutical Ingredients (APIs) falling under scope for a full ERA compared with the previous guidance. Previously an ERA was only required for a generic API where the new product would be expected to increase the amount entering the environment. Now most APIs initially registered prior to 2006 will require an ERA, many of which do not have relevant data.
wca have been developing approaches to meeting the new guideline requirements which includes the following:
- Designing a literature and database search strategy which can be applied to new and legacy APIs to identify data (published and proprietary) relevant for filling ERA data gaps;
- Conducting weight of evidence assessments to determine whether APIs meet EMA’s definition for endocrine active substances;
- Working with Contract Research Organisations to refine approaches to conduct toxicity testing at pHs relevant for the neutral form of the API (within the environmental pH range); and
- Conducting worst case secondary poisoning assessments to ensure that unnecessary fish testing is not conducted.
wca are highly experienced in supporting our pharmaceutical industry clients through a range of activities. If you have APIs which now fall under scope of the new guidance and require support in preparation of an ERA report, please do not hesitate to contact us.