Veterinary International Conference of Harmonization (VICH) has formed a working group to develop a common guide for the EU, Japan and the USA for the elaboration of Environmental Impact Assessments
Implementation, March 2009:
(2016.06.24) Guideline on environmental impact assessment for veterinary medicinal products in support of the VICH guidelines GL6 and GL 38
Implementation, November 2018:
(2018.04.30) Guideline on assessing the environmental and human health risks of veterinary medicinal products in ground water
For human medicines, there was no ICH guideline approach.
The US and EU have a different approach, as the EU has ruled separately on human and veterinary medicines.
It should be noted that generics are not exempt from providing an ERA and it is not possible to cross-reference the manufacturer's dossier without the manufacturer's consent.
Adopted, in application since 01/12/2006
Guideline on the Environmental Risk Assessment of medicinal products for human use EMEA/CHMP/SWP/4447/00 corr 2
Clarification and Harmonization (26/05/2016)
End of Consultation, 30/06/2019:
EMEA/CHMP/SWP/4447/00 Rev. 1
- New decision tree clarifying the need for studies and providing technical guidance to MA applicants to increase the consistency of their assessments
- Revised the term "endocrine active substances" to include all products that affect development or reproduction
- Introduction of the concept of exposure of predators to active substances in the food chain or the environment
- Limitation of laboratory tests
- For the calculation of the refined FPen, introduction of the prevalence "prevalence for the region with the highest prevalence”
You can check Tox by Design methodology for Environmental Risk Assessments, signed by an European Registered Toxicologist expert here.
In the event you are performing this exercise for innovative compounds GMP scale up manufacturing, please be noted Tox by Design is duly accredited for the French Research Tax Credit CIR.
Feel free to contact us using this email link to receive a quotation for Environmental Risk Assessments procedure.