ERA Environmental Risk Assessment Guidelines

EU ruled separately human and veterinary medicines.

Human Medicinal Products

There is no ICH guideline approach and USA and EU have a different approach.

Current Effective Version:

Guideline on the Environmental Risk Assessment of Medicinal Products for Human Use EMEA/CHMP/SWP/447/00 corr 2.

An Environmental Risk Assessment (ERA) is required for all new Marketing Authorisation applications through a centralized, decentralized, mutual recognition or national procedure or in case of an increase in environmental exposure.

No ERA is required for renewals or type IA/IB variations.

This guideline is under revision: Revised Guideline on the Environmental Risk Assessment of Medicinal Products for Human Use EMEA/CHMP/SWP/4447/00 Rev. 1

That revision:

  • Introduce a decision tree, clarifying need of further studies, giving technical guidance to applicants in order to bring greater coherence to their evaluation
  • Precise the term “endocrine active substances” by including all products affecting development or breeding
  • Introduce exposition notion of predators Active Substance exposure for food chain or environment
  • Limit laboratory tests
  • Introduce in Market penetration refined factor (Fpen refined) calculation, prevalence for the strongest prevalence region

Veterinary Medicinal Products

European legislation requires all veterinary medicines to undergo an environmental risk assessment based on their expected use.

The ERA is an evaluation of the possible hazards to the environment posed by a veterinary medicine.

The ERA considers solely the use of the medicine and the physico-chemical, ecotoxicological, and fate properties of its active substance.

Current Effective Guidelines:

Guideline on Environmental Impact Assessment for Veterinary Medicinal Products in Support of the VICH Guidelines GL6 and GL38 EMA/CVMP/ERA/418282/2005-Rev.1 Corr. (Last updated: 24/06/2016)

Guideline on Assessing the Environmental and Human Health Risks of Veterinary Medicinal Products in Groundwater EMA/CVMP/ERA/103555/2015 (Last updated: 30/04/2015)

You can check Tox by Design methodology for Environmental Risk Assessments, which are duly validated and signed by an European Registered Toxicologist expert.

In the event you are performing this exercise for innovative compounds GMP scale up manufacturing, please be noted that Tox by Design is duly accredited for the French Research Tax Credit CIR.

Feel free to contact us using the Quotation Request below to receive a quotation for Environmental Risk Assessment of your drug products.