Environmental Risk Assessment (ERA) / Environmental Assessment (EA)

There is an increasing public awareness of potential concerns associated with pharmaceuticals in the environment. As a result, a requirement for an environmental risk assessment (ERA) into applications for marketing authorisation was implemented by numerous countries worldwide.

In the EU, the ERA assessment is demanded in accordance with Article 8(3) of Directive 2001/83/EC, as amended. The requirements are specified in guideline EMEA/CHMP/SWP/4447/00 corr 2 (implemented in 2006; revision is pending). The obligation covers all new marketing authorization applications for a medicinal product through a centralised, mutual recognition, decentralized or national procedure irrespective of the legal basis (i.e. also Article 10(1/2) (generic), Article 10(3) (hybrid), Article 10a (well-established use/bibliographical), Article 10b (fixed combinations), Article 10c (informed consent) and Article 10(4) (similar biological applications)).

In the USA, FDA demands in 21 Code of Federal Regulations part 25 that environmental assessments (EAs) must be submitted as part of new drug applications (NDAs), abbreviated applications, applications for marketing approval of a biologic product, supplements to such applications, and investigational new drug applications (INDs) unless the action qualifies for categorical exclusion.

Other countries frequently refer to either the EU or the US guidelines for environmental testing.

While some differences exist between the requirements of environmental testing for an ERA or EA between the EU and the USA, both systems are similar in the overall strategy: As a first step, the potential environmental exposure is determined. If it exceeds the respectively defined action limit or if other concerns are apparent, defined sets of environmental studies are demanded. These need to be performed according to relevant guidelines, e.g. OECD 106, OECD 308, OECD 201. Depending on the outcome of the first set of studies (Phase I), additional sets of studies may be required (Phase II Tier A, Tier B) These sets of studies overlap between EU and US guidelines. Both regions foresee the possibility to waive the conduct of experimental studies under certain circumstances.

PharmaLex has broad experience in strategic approaches to environmental risk assessments regarding the argumentation for a waiver, the organization and monitoring of studies at external service laboratories and the compilation of the required expert report (ERA in Europe, EA in the USA).

Among our services are;

  • Strategic evaluation of the necessity to conduct Phase I and/or Phase II environmental studies
  • Support at Scientific Advice Meetings with Health Authorities in the EU and USA
  • Literature searches for a bibliographic document
  • Argumentation to waive environmental studies
  • In case a waiver is not possible, selection of GLP-certified research laboratories for the conduct of environmental studies
  • Study monitoring and program management
  • Alignment of studies with both EU and US guidelines, such that they can be accepted in both regions
  • Writing of ERA/EA documents (including application for waivers or partial waivers, discussion of literature, implementation of results from Phase I and II studies)
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