Unlocking Cost Efficiency & Harmonisation for Generic Pharmaceuticals

The Environmental Risk Assessment (ERA) of generic human pharmaceuticals is entering a new era of scrutiny. Both the European Medicines Agency (EMA) and the UK Medicines & Healthcare products Regulatory Agency (MHRA) are increasingly requiring full environmental data packages for generic pharmaceutical applications – an evolution that reflects the growing priority placed on environmental protection under EU and UK frameworks.

New ERA Requirements for Generics in the EU and UK

Historically applications for generic products could avoid in-depth ERAs by arguing that authorisation would not lead to increased environmental exposure. However, this approach is only accepted under the new guideline if a full ERA is available for the reference drug product. In cases where no previous ERA was submitted, e.g. original submission occurred before 2006, or the previous ERA does not meet the requirements of the current guidelines, new or updated ERAs will need to be submitted.

This shift aligns with broader environmental objectives across the EU and UK, ensuring that all pharmaceuticals are assessed for their potential impact on ecosystems, consistent with guidance under Directive 2001/83/EC and UK Human Medicines Regulations 2012.

Costly Duplication of Data for Pharmaceutical Manufacturers

Meeting ERA requirements can mandate the generation of high-quality data on the physico-chemical properties, environmental fate, and ecotoxicity of active substances, in accordance with Good Laboratory Practice (GLP). These studies cover complex endpoints such as biodegradability, bioaccumulation, aquatic toxicity, and terrestrial toxicity, and are both technically demanding and expensive.

For generic pharmaceutical manufacturers working independently, this means multiple companies could be commissioning duplicate studies for the same active ingredient, which is an inefficient use of animals, resources, time, and laboratory capacity, with testing programmes approaching the half million euro mark for a single active ingredient.

Data Sharing Through Pharmaceutical Consortium Collaboration

Following precedents set in the EU chemicals and biocides sectors, formation of data sharing consortia offers a practical solution for generic pharmaceutical manufacturers. Under the REACH Regulation, data sharing has long been used to avoid unnecessary testing, reduce costs, and harmonise the scientific assessment of chemical substances.

By establishing a consortium for pharmaceutical ERA data, generic manufacturers have the opportunity to:

• Share costs for new environmental data generation,
• Ensure harmonised environmental endpoints that support consistent risk assessments,
• Reduce regulatory uncertainty through alignment on robust, peer-reviewed datasets,
• Facilitate engagement with regulators through a unified industry position on ERA evidence.

Pioneers in Consortium Management

At Blue Frog Scientific, we have been at the forefront of data sharing and consortium management since 2008. Our experience spans the formation, governance, and long-term coordination of large industry groups across the chemicals sector, under EU REACH, UK REACH, and related frameworks.

We continue to manage multi-company consortia responsible for data ownership, cost sharing, and communication with regulatory authorities, ensuring transparency, fairness, and full compliance with data sharing legislation and competition law.

Ready-to-Implement Data Sharing for Generic Pharmaceuticals

Not only does Blue Frog Scientific have a wealth of experience in conducting comprehensive Environmental Risk Assessments (ERA) for human medicinal products, but we also offer a ready-to-implement data sharing service, tailored for the generic pharmaceuticals market. Our model enables companies to rapidly form or join a consortium, generate or gain access to shared environmental data, and collectively fulfil ERA obligations, saving time, reducing cost, and strengthening regulatory confidence in the shared dataset.

This collaborative approach will reduce duplication and uncertainty, as well as contributing to a more sustainable, harmonised, and scientifically robust understanding of the environmental profile of human pharmaceutical active substances across the EU and UK.

If you're interested in joining, or forming, a pharmaceutical ERA consortium, call or email and one of our consortium management specialists will be in touch to discuss how we can help you establish a cost-effective data sharing framework for your active ingredient portfolio.