The BPI/E&A-ERA Pooling Project

Current requirements for the environmental assessment of medicinal products are based on the EMA guideline (EMEA/CHMP/SWP/4447/00 Rev. 1 – Corr.*). The ERA profile of medicinal products also plays a central role in the current reform of pharmaceutical legislation within the framework of the EU Pharmaceutical Package.

All new marketing authorisations for medicinal products in the EU are subject to the current environmental assessment requirements, regardless of the regulatory procedure. Whether centralised procedure (CP), decentralised procedure (DCP), national procedure, or mutual recognition procedure (MRP, RUP): an ERA is mandatory and has been expanded compared to the 2006 guideline with additional requirements. A simple waiver is no longer sufficient.

The requirement to submit an ERA applies in the following cases:

• Variations and line extensions of marketing authorisations,
• Renewals, where new relevant environmental data become available or environmental exposure changes,
• Generics: An ERA is also required. However, access to existing ERA data of the reference product may be granted via a Letter of Access (LoA), provided that the data owner agrees and the data are complete and compliant with current requirements.

For so-called legacy substances (authorised before October 2005), the situation is often particularly challenging, as no environmental assessment was required at the time of authorisation. As a result, data availability is limited and environmental information is often scarce.

In addition, ERAs are not static documents. They must be updated regularly. Continuous monitoring is required to identify potential risks at an early stage and to ensure ongoing regulatory compliance.

Independently of this, alignment with the relevant authorities may be advisable or required in individual cases.

We support you throughout this entire process: from the generation of high-quality data and EMA guideline-compliant reports to the implementation of continuous ERA monitoring and professional communication with the competent authorities.

We also offer continuous ERA monitoring as a standalone service. Building on our established Continuous Benefit-Risk Assessment (CoBRA) process for signal management in pharmacovigilance, we can specifically extend this framework to include ERA monitoring—either as an add-on or as a separate solution, depending on your needs. The organisation of consortia for the joint preparation of ERAs is explicitly encouraged by regulatory authorities in order to enable efficient data sharing, reduce costs, and avoid duplication of work. This is exactly where our pooling concept comes in: We support you as an MAH with our expertise in the organisation and implementation of such consortium-based solutions within the framework of our ERA Pooling Project.

The offering is aimed at pharmaceutical companies (Marketing Authorisation Holders, MAHs) that are required to prepare or update an ERA for any human medicinal product at the API level in order to meet regulatory requirements.

Does this apply to you?

• Do you have multiple active substances in your portfolio and need to meet ERA requirements for several legacy products?
• Are you planning a variation, renewal or marketing authorisation of a legacy product? 
• Was your medicinal product approved before October 2005 and does it contain an established active substance? Then a retrospective ERA for compliance could be relevant for you – also in the generics sector. 
• Do you already have environmental data and want to use it efficiently or supplement it strategically? 

We will host a general information event on 5 June 2026, together with the BPI, during which the project will be officially launched.You are also welcome to contact us in advance at: ERA@ebeling-assoc.com and ERA-Pooling@bpi.de.

Register here

The initial outreach to potential project participants is carried out by both the BPI and E&A. As part of this process, an initial API-specific allocation and consortium formation takes place, which is continuously supported by E&A. Subsequently, we at E&A take over the full coordination of the consortia, providing you with a fully managed ERA solution.

Upon official project entry, a general data request is conducted among all participating MAHs, along with an orientating literature and database review to determine the current status for the respective API. On this basis, the API’s risk profile is ultimately classified and assessed according to PBT criteria (Persistent, Bioaccumulative, Toxic), taking into account an external subject matter expert (SME). This determines the subsequent project progression and the scope of studies required. Based on this, the costs for the following Phase A are estimated and communicated to the consortium.

Phase A (Data assessment) comprises a comprehensive gap analysis, including the literature and database review. Existing data are assessed for completeness and suitability in accordance with the Criteria for Reporting and Evaluating Ecotoxicity Data (CRED). Where usable data from a consortium member are available, we coordinate a cost-sharing mechanism under which the respective MAH is reimbursed proportionally by the other consortium members. In return, all members receive usage rights. In addition, we will contact other MAHs/originators on your behalf to request access to relevant ERA data, if applicable. At the end of Phase A, a preliminary Joint API ERA Report is prepared. At the same time, in consultation with the SME, we will issue a study recommendation for any necessary further study to address identified gaps.

In Phase B (Study execution), the recommended studies are conducted by qualified contract laboratories with which we collaborate. The study results are compiled into a final, compliant Joint API ERA report and submitted to the consortium. 

We would like to explicitly point out that, upon request, we also prepare product-specific ERAs, as the joint report must still be individually adapted by each participating MAH to the specific characteristics of the respective medicinal product. This is done on the basis of a separate quotation provided upon request.

The ERA Pooling Project: At the beginning, interested MAHs are grouped into API-specific consortia. In Phase A, existing data are first reviewed, and a thorough literature and database search is conducted as part of a gap analysis, on the basis of which study recommendations may be issued. In the subsequent Phase B, the recommended studies are carried out and analysed, ultimately resulting in the preparation of a Joint API ERA Report for the consortium. API: Active Pharmaceutical Ingredient.

The costs strongly depend on the consortium and vary according to the API as well as the associated effort. The more MAHs join a consortium, the lower the individual costs, as these are distributed evenly among the participating MAHs.

For further information or an initial consultation, please feel free to contact us at:
ERA@ebeling-assoc.com.

With our extensive experience in regulatory dossier preparation and the management of marketing authorisation procedures, as well as our established network of qualified laboratories and regulatory contacts, we offer an efficient and structured implementation of your ERA project within a consortium.

You benefit from:

• A significant cost reduction through collaboration within a consortium. 
• A Centralised and efficient coordination of all project activities by an experienced service provider. 
• A structured and critical evaluation of all relevant data with the involvement of an external subject matter expert (SME). 
• Our established network of ecotoxicology laboratories and contacts with relevant authorities. 
• Coordinated acquisition of Letters of Access (LoA) to optimise the use of existing data. 
• High-quality ERA data in accordance with regulatory guidance. A fully integrated ERA process – from data collection to the final scientifically substantiated API ERA Report.