Pharmaceuticals
Our team of pharmaceutical experts at ECT compiles dossiers for the environmental risk assessment of medicines:
- For human-use medicinal products according to the recently revised EMA guideline (EMEA/CHMP/SWP/4447/00 Rev. 1-Corr.)
- For veterinary medicinal products according to EMA/CVMP/VICH guidance (particularly VICH GL 6 and GL 38)
Our experts are familiar with all parts and tiers of the environmental risk assessment of pharmaceuticals. Since more than 20 years, we have participated in national and international research projects that developed comprehensive knowledge around pharmaceuticals in the environment (PiE) and methods for assessing their environmental risks (e.g. ERAPharm, iPiE and PREMIER). Based on our expertise in generating the required experimental data in GLP-conform studies as well as conducting the environmental risk assessment, we can support you during all steps of the environmental risk assessment. In addition, literature reviews for legacy pharmaceuticals can be prepared. We can provide scientific expert advice also in complex cases, regarding e.g. specific modes of actions, higher tier testing and risk management options.
ECT supports your company throughout the complete environmental risk assessment procedure for human and veterinary medicines by providing the following services:
- Identification of data requirements & gaps and development of assessment strategy
- Data mining and literature search
- Relevance and reliability assessment of the identified public data
- Performing the required environmental fate and effect studies according to Good Laboratory Practice (GLP) including placing of fate simulation studies that cannot be conducted in-house
- Conducting Phase I and II of the environmental risk assessment for human as well as veterinary pharmaceuticals
- Dossier preparation (CTD Module 1.6 for human medicines, assessment report for veterinary medicines)
- Providing expert opinion reports on specific questions regarding e.g. targeted effects assessments, exposure and risk management
- Communication with the competent authorities
For a list of our most relevant publications on pharmaceuticals in the environment see here.
