The German Pharmaceutical Industry Association has launched the ERA Pooling Initiative, a collaborative project enabling marketing authorisation holders to share environmental data, reduce duplicative testing and meet tightening regulatory requirements.
The German Pharmaceutical Industry Association (BPI) has launched the ERA Pooling Initiative, a new industry-wide project developed in collaboration with Dr. Ebeling & Assoc. GmbH (E&A) as service provider to help pharmaceutical companies address increasingly stringent environmental requirements for medicinal products under evolving European legislation.
The initiative responds to major regulatory developments currently reshaping the pharmaceutical sector in Europe.”
The initiative responds to major regulatory developments currently reshaping the pharmaceutical sector in Europe. The revised EMA Guideline EMEA/CHMP/SWP/4447/00 Rev. 1 – Corr. on Environmental Risk Assessment (ERA) which entered into force in September 2024, together with the forthcoming EU Pharmaceutical Package, significantly expands environmental obligations for marketing authorisation holders (MAHs). Environmental considerations are becoming an integral component of the regulatory review process and companies will be expected to provide scientifically robust and up-to-date environmental data for their products.
Under the proposed legislation, incomplete or inadequate environmental risk assessments may result in regulatory delays, requests for additional studies or, in certain cases, the refusal of marketing authorisations. The new framework also applies to active pharmaceutical ingredients (APIs) that were authorised before the introduction of current ERA requirements in 2005 and for which comprehensive environmental datasets are often unavailable.
To support pharmaceutical companies in addressing these challenges, BPI has established the ERA Pooling Project together with E&A. The project provides a collaborative framework through which companies can pool and share existing environmental data, identify data gaps and generate additional ERA data where required. By working together through dedicated API consortia, participants can reduce costs, avoid duplication of studies, and improve the quality and consistency of environmental documentation. All scientific, regulatory and organisational activities are centrally managed by E&A.
A key objective of the initiative is to support the data-sharing principles outlined in the revised EMA guideline”
A key objective of the initiative is to support the data-sharing principles outlined in the revised EMA guideline and follow the demands of regulatory authorities. The guidance encourages collaboration among marketing authorisation holders and promotes the use of existing environmental data wherever possible in order to avoid unnecessary duplicate studies. The ERA Pooling Project provides a structured mechanism for implementing these principles in practice.
The project has been designed as a long-term and continuously expanding initiative and is open for every interested MAH. Additional APIs will be incorporated on an ongoing basis, reflecting regulatory priorities and industry demand. This approach enables companies to participate in API-specific consortia relevant to their portfolios.
Companies interested in participating in current or future ERA consortia are invited to contact BPI or E&A for further information regarding upcoming API programmes and participation opportunities at ERA-Pooling@bpi.de or ERA@ebeling-assoc.com.
No comments yet