Environmental Risk Assessment Services for Human and Animal Drug Products

Environmental Risk Assessment Services for Human and Animal Drug Products

Environmental Risk Assessment (ERA) services for human and animal drug products involve a comprehensive evaluation of the potential environmental impacts that may arise from the use, storage, and disposal of medicinal products. These services are designed to ensure that the risks to the environment are identified, assessed, and managed effectively, in compliance with regulatory requirements.

For human medicinal products, the ERA process follows the guidelines set out in EU Directive 2001/83/EC, which outlines a stepwise, two-phase procedure. The first phase estimates the environmental exposure to the drug substance by calculating the predicted environmental concentration (PEC). If the PEC indicates a potential risk, a more detailed assessment is conducted in the second phase. Since 2006, an ERA is required according to EMA guideline (CPMP/SWP/4447/00, 2006) and according to document "Question and answer on Guideline on the environmental risk assessment of medicinal products for human use" (EME/CHMP/SWP/44609/2010 Rev. 1, 2016) for all new marketing authorization applications (MAA) in the Europe for medicinal products, including those for generics. In the United States, environmental assessments (EAs) must be submitted as part of certain new drug applications (NDAs), abbreviated applications (ANDAs), investigational new drug applications (INDs), and various other actions.

For animal drug products, the ERA process may involve similar steps, with particular attention to the potential for drugs to enter the environment through excretion from treated animals and impact non-target species and ecosystems.

Our ERA services include:

• ERA Tier I and Tier II Assessment of human and animal pharmaceuticals
• Justification for ERA waiver preparation for generics
• Interaction with environmental competent authorities.
• Screening for Persistence, Bioaccumulation and Toxicity (PBT)
• Ecological effects study summaries preparation in format similar to ECHA dossier
• Hazard evaluations conducted in accordance with internationally recommended methodologies.

The goal of ERA is to estimate the likelihood of adverse effects on humans, other species, and ecological systems, and to implement appropriate risk management strategies to mitigate these risks. This includes providing information on the safe use, storage, and disposal of medicinal products to healthcare professionals and the public, as reflected in the Summary of Product Characteristics (SmPC) and labelling information.

For any query on ERA and product compliance queries from health authorities, you can reach out to us. Thank you!