Environmental Risk Assessment Service for Generic Human Medicinal Products
Generic pharmaceuticals are now under far greater scrutiny for their environmental impact and subject to thorough environmental risk assessments (ERAs).
Following the September 2024 update to the EMA guidelines, a more thorough ERA is now required for marketing authorisation applications under Article 10 of Directive 2001/83/EC, including Art 10(1) – generic medicinal products.
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 / updated ERAs will need to be submitted.
Blue Frog Scientific has a wealth of experience in conducting comprehensive Environmental Risk Assessments (ERA) for human medicinal products and is well placed to support the needs of Applicants looking to market generic drugs in Europe. Our team can provide support for all aspects of the environmental risk assessment of generic drugs, including but not limited to; initial strategy development, production of waivers, data mining, data generation through study monitoring, ERA calculations and refinement, production of an expert report for inclusion in module 1.6 and defence of the ERA during regulatory evaluation.
Our approach has evolved with regulatory expectations – ensuring that each risk assessment is delivered to the highest standards of scientific rigour to help efficiently achieve regulatory compliance.
Comprehensive ERA Development
Initial Scoping & Refinement
We collaborate with clients to define the scope of the ERA, considering all regulatory requirements, possible waivers and potential study refinements before initiating any tests.
Project Management
Depending on your needs, our involvement can range from managing the entire project to overseeing specific segments. Our flexible approach is designed to integrate seamlessly with your internal processes and capabilities.
Study Execution & Oversight
Commissioning & Monitoring Studies
We manage all aspects of study execution, from commissioning through to final reporting, including real-time troubleshooting and quality control. Our scientific team, comprising professionals with extensive leadership backgrounds, ensures that all tests are appropriately designed and conducted to meet the specific needs of the ERA.
Review & Analysis
Our experts rigorously review study plans and reports to ensure compliance with both scientific and regulatory standards.
GLP Study Monitoring
We oversee studies ensuring they adhere to Good Laboratory Practice (GLP) regulations, ensuring data integrity and regulatory acceptance.
Regulatory Documentation & Support
ERA Report
We prepare a detailed Phase I and/or Phase II ERA report for inclusion in Module 1.6 – tailored to meet EMA and other relevant regulatory body requirements.
Post-Submission Support
We provide robust defence and support throughout the regulatory review process, addressing any issues that arise post-submission to facilitate approval.
Additional Regulatory Services
Pre-Testing QSAR Evaluation
We use QSAR models to predict fate and effects, aiding in budgetary forecasts and the development of targeted testing strategies.
Data Mining & Literature Reviews
Our team performs extensive literature searches and data mining to gather relevant data and identify structurally related molecules, enhancing the robustness of our assessments.
CRO Liaison
We coordinate with Contract Research Organisations to obtain quotes and schedule studies efficiently, ensuring your project remains on track.
If you have any queries relating to environmental risk assessments for pharmaceuticals, call today and speak with one of our pharmaceutical regulatory specialists. We'll guide you through the intricacies of these fast evolving requirements, in order to maintain market access and full regulatory compliance.
