Environmental Risk Assessment (ERA) - Overview
The Environmental Risk Assessment (ERA) of medicinal products for human use is an essential process to ensure that potential environmental effects of pharmaceuticals are studied, and appropriate precautions are taken if specific risks are identified.
ERA involves evaluating the potential impacts of pharmaceuticals on the environment, particularly after they have been excreted by humans or animals and subsequently enter ecosystems through various pathways such as sewage systems or runoff. This process typically involves assessing both the fate (i.e., how the substance behaves and moves within the environment) and hazard profiles (i.e., the potential of the substance to cause harm to organisms) of pharmaceutical compounds. ERA assessment takes into consideration factors like persistence, bioaccumulation, toxicity, and predicted environmental concentration (PEC).
Some key regulatory guidelines/guidance related to ERA are -
- European Medicines Agency (EMA) - Guideline on the environmental risk assessment of medicinal products for human use (EMEA/CHMP/SWP/4447/00)
- US FDA guidance of Environmental Assessment of Human Drug and Biologics Applications, 1998.
- Australian guidance for Environmental Risk Assessment Guidance Manual for industrial chemicals, 2009
- U.S. Environmental Protection Agency (EPA) - EPA offers guidance, handbooks, and framework documents for conducting risk assessments based on sound science
The key components of an ERA for pharmaceuticals are the identification of pharmaceuticals of concern and the assessment of their fate. This aspect of the assessment focuses on understanding how pharmaceutical compounds behave once they are released into the environment. Factors such as degradation, bioaccumulation, transport, and transformation pathways are considered. For example, some pharmaceuticals may degrade rapidly in sunlight or water, while others may persist for long periods.
The Environmental Risk Assessment (ERA) involves the following key steps:
- Hazard Identification: Identification of potential effects that adversely affect humans or ecosystems.
- Toxicity Assessment: Assess and evaluate the harmful effects on the health of ecological receptors.
- Exposure Assessment: Estimation of how much contact humans or ecosystems have with the contaminated environment.
- Risk Characterization: Predict the probability, nature, and magnitude of adverse effects that might occur due to environmental contamination.
While performing an ERA assessment for aquatic ecosystems, evaluation of the following specific endpoints is crucial.
- Receptors: Identification of specific receptors likely to be affected such as species, communities, or ecosystems
- Characterisation of effect – Identify the impact or effects on the receptors, such as survival, growth, or reproduction
These endpoints help determine the potential risks to the environment.
Environmental Risk Assessment (ERA)
- Extensive reports in full compliance with regulatory guidelines with complete supporting data/information
- Reports reviewed/approved by qualified toxicologists.
- Use of highly scientific approaches and methodologies for performing ERA
- Tiered assessment and prompt update/communication on the level of assessment required
- Reports developed for novel or new chemical entities and complex pharmaceuticals
- Highly experienced and board-certified team (American Board of Toxicology and European Registered Toxicologists).
- Clear understanding of relevant Regulatory guidelines.
- Comprehensive reports, encompassing detailed evaluation, hazard identification, and risk assessment.
- Quick turnaround and priority delivery based on the urgency and requirement of the customer.
- Well-established and structured literature search strategy.
- Robust quality control checks, right from document compilation to the sign-off stage.
- 24x7 regulatory support on regulatory or audit queries.
