January 13, 2026 by Olivia Tran
wca have been working with pharmaceutical innovators and generics companies on environmental risk assessments (ERA) since the European Medicines Agency (EMA) published their original guidance on conducting ERAs in 2006. A number of our staff also previously worked in the pharmaceutical sector on ERA related activities, helping to shape the ERA guidance.
A revised and updated version of the EMA ERA guidance was published in September 2024, and all ERAs submitted as part of pharmaceutical marketing authorisation applications (MAAs) must comply with this new guidance. For many pharmaceuticals already on the market, this has generated a need for existing ERAs to be updated, or for the development of completely new ERAs. Working with pharmaceutical companies across the sector on the development of the optimal approaches to address the requirements of the new ERA guidance, we have gained some valuable insight on how medicines authorities are implementing the guidance through feedback on recently submitted ERAs.
A key new addition in the guidance is the requirement for a targeted literature search for any new information of significance to the ERA. wca worked with a major pharmaceutical innovator to develop a systematic literature search procedure to retrieve existing ERAs and data relevant to the ERA from scientific literature and grey information sources. The search strategy was developed based on our experience conducting literature searches for industrial chemicals and pesticides under the European Union (EU) Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) and Plant Protection Product (PPP) Regulations and is therefore aligned with best practice under EU chemical frameworks. This work was presented at the Society for Environmental Toxicology and Chemistry (SETAC) 2025 European conference; please contact us to obtain a pdf copy of the poster.
A common request from regulators is an update to the predicted environmental concentration in surface water (PECsw) for Phase I ERAs of new marketing authorisation applications (MAAs). In many previous ERAs, the PECsw was calculated using a market penetration factor (Fpen) based on market sales data, which was permitted under the previous guidance. However, the revised guidance makes clear that the Fpen can only be refined based on treatment regime and current European disease prevalence data, ideally published within the last five years. We have seen a number of authority requests to recalculate the Phase I PECsw using prevalence data with supporting scientific justification. To address this, we have been successful in preparing updated ERAs with robust justifications for prevalence refinements based on data from scientific literature and authoritative databases, and these have been accepted by regulators. We endeavour to refine the Phase I PECsw as far as possible (e.g., for specific patient populations) to obtain a more realistic value for risk assessment.
For pharmaceuticals requiring Phase II assessment, data on environmental fate and effects are required, and, for many pharmaceuticals, such data are not available in the published scientific literature (or at least sufficiently reliable data are not available). Reliable and relevant data may have been generated for the original MAA, and the ERA guidance now requires new applicants to submit a Letter of Access if they wish to use the originator’s data to support their own ERA/ MAA. Generic pharmaceutical manufacturers have highlighted difficulties in obtaining Letters of Access to environmental data from the originator, whilst most data owners do not have a formalised procedure for dealing with the sale of (often quite old) data. Our initial experience with recently submitted ERAs suggests that regulators are understanding of the situation and typically willing to accept summary information published in regulatory reports where ERA outcomes have been previously assessed by the EMA (in line with the Phase I decision tree) and the ERA outcomes would not change, thus circumventing the need for formal data sharing. Where data sharing is required, wca are able to facilitate data sharing for pharmaceutical ERA by leveraging our extensive experience of consortium management (through our REACH activity) to assist both data owners and generic pharmaceutical manufacturers. This includes the development and ongoing administration of cost-sharing mechanisms and data management systems to enable Letters of Access and requests for data to be dealt with efficiently by data owners, as well as the establishment of consortia which may assist generic pharmaceutical manufacturers in accessing, generating and sharing the relevant data.
For Phase II assessment, we are experienced in evaluating data gaps according to the revised ERA guidance and can guide you through the data generation process. wca have established a network of reputable laboratories for environmental testing and can help you to select a cost-effective laboratory for scientifically robust data generation. We are also able to support in study monitoring and can advise on difficult to test substances, such as ionisable pharmaceuticals which may have different fate and effect outcomes at different environmentally relevant pH levels. The revised ERA guidance contains specific considerations for testing ionisable substances and we have already gained considerable experience of accounting for these considerations in studies with fish, Daphnia and sediment organisms.
Please get in touch if you require a literature search, support in preparing an ERA for your pharmaceutical product, or support for establishing data sharing mechanisms.