December 7, 2018 by Becky Brown
The European Medicines Agency (EMA) have published draft revised guidelines for assessing the environmental risks of medicines in the environment (EMA 2018)1. The guidelines are published with a six-month consultation period and stakeholders are invited to provide comments by 30th June 2019.
This represents the first major revision of the guidance since 2006. The proposed updates include changes to the data requirements for a pharmaceutical environmental risk assessment (ERA). Notably the OECD 308 water /sediment simulation study is no longer an obligatory Phase II Tier A study requirement, although data from this study may be used for refinement of the risk assessment in Tier B or a persistence bioaccumulation or toxicity (PBT) assessment. The new guidance also allows for tailored risk assessments for some types of substance (e.g. endocrine active substances and antibiotics). There is more technical detail provided on the required environmental tests which is hoped to improve the consistency of assessments. There are new sections providing details on the specific requirements for addressing endocrine active substances (EAS), PBT assessments, and secondary poisoning.
Some other changes to the guidelines include:
- A Phase I decision tree which includes a requirement to confirm that non-natural peptides or proteins are ready biodegradable before concluding that no further information is required;
- Additional data requirements for physico-chemical properties (water solubility at three pH’s and dissociation constants) under Phase II Tier A;
- A sediment risk assessment is now required rather than triggered;
- Trigger values are provided for groundwater, soil and secondary poisoning assessments which are all addressed as part of the Phase II Tier A risk assessment;
- For the terrestrial risk assessment an earthworm reproduction study is required rather than an acute toxicity test.
Although in draft form our experience has found that the regulator is already referring to the guidance in their assessments. Please contact me if you need help with an environmental risk assessment for your medicinal product or would like to understand how these changes might impact your active pharmaceutical ingredients.
¹EMA (2018) Guideline on the environmental risk assessment of medicinal products for human use (draft) EMEA/CHMP/SWP/4447/00 Rev. 1. 15 November 2018; https://www.ema.europa.eu/en/news/revised-guidelin...