Revision of the EMA “Guideline on the environmental risk assessment (ERA) of human medicines”
The EMA published a revision of the “Guideline on the environmental risk assessment (ERA) of human medicines” on 30 November 2018. The guideline is now open for public consultation until 30 June 2019.
The purpose of the ‚Guideline on Environmental Risk Assessment of Medicinal Products for Human Use‘ (EMEA/CHMP/SWP/4447/00 Corr 2) is the identification of potential harmful effects of pharmaceuticals on the environment and the implementation of appropriate precautionary measures. Thus, the submission of an environmental risk assessment (ERA) as a part of the dossier is mandatory for pharmaceuticals irrespective of the type of procedure. In 2014 the Safety Working Party of the Human Medicines Committee (CHMP) issued a concept paper recommending the revision of the ERA guideline that had been in place unchanged for 10 years at that time. In particular, experience gained with the guideline so far as well as newly developed scientific methods and additional relevant documents were deemed necessary to be taken into account.
The following aspects of the revised guideline are in particular noteworthy:
- A decision tree with a Q&A-section has been introduced for the Phase I risk assessment. The decision tree also comprises applications under Art. 10 of Directive 2001/83/EC.
- Technical details for studies conducted as a part of the phase II risk assessment have been included.
- The term “endocrine disruptors” has been replaced by “endocrine active substances” to include all substances potentially affecting development and reproduction.
- OECD test 308 (Aerobic and Anaerobic Transformation in Aquatic Sediment Systems) – currently obligatory for the phase II risk assessment – will be limited to certain categories of substances.
- A new section on secondary poisoning was introduced to estimate the accumulation of active substances in the food chain.
- Following the principles of the 3Rs (Replacement, Reduction and Refinement) Applicants are encouraged to share their data to avoid unnecessary repeating of studies with living organisms.
The document informs about potential far-reaching changes of the assessment of potential environmental risks of human medicines and is open for public consultation until 30 June 2019.
- Draft guideline on the environmental risk assessment of medicinal products for human use - Revision 1 (https://www.ema.europa.eu/en/environmental-risk-assessment-medicinal-products-human-use)
- Guideline on the environmental risk assessment of medicinal products for human use - EMEA/CHMP/SWP/4447/00 corr 2 (https://www.ema.europa.eu/documents/scientific-guideline/guideline-environmental-risk-assessment-medicinal-products-human-use-first-version_en.pdf)
- Template for submission of comments (https://www.ema.europa.eu/en/news/revised-guideline-assess-risk-human-medicines-environment)