Environmental Risk Assessment Services
Charles River provides a comprehensive portfolio of ecotoxicology and environmental fate (eFate) services in accordance with the existing guidance documents. We can arrange initial evaluation of potential environmental exposure and risk following review of usage patterns and available environmental effects data as well as phased refinement of the ERA. We can also liaise with authorities and consultants regarding the detailed design and scientific justification of any nonstandard tests that may be required.
EMA Revises the Guideline for Environmental Risk Assessment of Medicinal Products for Human Use
EU Tiered Approach
Since 2006, an environmental risk assessment (ERA) is required for all new marketing authorization applications (MAA) for medicinal products, including those for generics. The procedure described by the European Medicines Agency (EMA) follows a tiered approach.
FDA Tiered Approach
In the US, environmental assessments (EAs) must be submitted as part of certain new drug applications (NDAs), abbreviated applications (ANDAs), investigational new drug applications (INDs) and for various other actions, unless the action qualifies for a categorical exclusion (CE) based on an expected environmental concentration of the active moiety below 1 ppb and a claim for no extraordinary circumstances.
Environmental Risk Assessment for Pharmaceuticals in Japan
In March 2016, the Ministry of Health, Labour and Welfare (MHLW) in Japan released the Guidance of Environmental Risk Assessment (ERA) on New Pharmaceuticals1, which explains the requirement of Predicted Environmental Concentration (PEC) calculation and testing of environmental toxicity and fate.
The MHLW Guidance is the only official document that is now referred to for assessment of adverse effects against the environment in Japan caused by exposure of marketed pharmaceuticals through uptake in the patients followed by excretion and disposal via wastewater. However, contrary to the guidances adopted in EU and US, details on PEC calculation and environmental testing are not included in the MHLW guidance. Therefore, it is difficult for pharmaceutical companies to estimate the cost associated with ERA for their authorization applications in Japan in the forthcoming future.
From a global perspective, ERA assessments follow step-wise approaches that characterize the potential risk of the pharmaceuticals. Particularly in the EU, the tiered approach is well described for the ERA, starting with a screening Phase I and leading into testing Phase II (Tiers A and B). At the 2019 meeting of JSOT, Charles River scientists presented a poster comparing the ERA scheme currently suggested in Japan to that used in the EU, and discusses the potential consistency of PEC calculation and testing for environmental toxicity and fate that should be taken into consideration by pharmaceutical companies in Japan. Download your copy
Supporting your ERA program
With extensive experience in study design across multiple industrial sectors, our team has a thorough understanding of these unique regulatory requirements, from study design to the review and interpretation of data. We can assist clients in the pharmaceutical arena with the design of programs and studies tailored to the properties of their medicinal product.
Environmental Risk Assessment Frequently Asked Questions (FAQs)
What studies are included in an Environmental Risk Assessment for a pharmaceutical?
An Environmental Risk Assessment (or (ERA) can consist of physicochemical, environmental fate and ecotoxicity studies. The final program design will be dependant on the properties of the medicinal product, usage and existing data.
What is an Environmental Impact Assessment?
An Environmental Impact Assessment (EIA) is a the veterinary medicinal product equivalent to an ERA. Similar studies will be required, but the final program design will also be dependant on the intended market. There are differences in the registration requirements between Europe and the United States, for example.