An environmental risk assessment (ERA) is required for all marketing authorisation applications for human medicinal products (Article 8(3) of Directive 2001/83/EC). This requirement applies, with some exceptions, to all new medicinal products, as well as new applications for generic medicinal products. The environmental impact should also be evaluated for type II variations and extension applications to existing marketing authorizations, if a potential increase in environmental exposure is likely.

Conducting the ERA is a tiered process, starting in Phase I with a desk exercise. An exposure estimate based on the proposed dosage is compared against a default action limit. If this limit is exceeded, a full risk assessment of the environmental fate and effects of the active ingredient is required (Phase II). The availability of data is likely to vary considerably between new and generic medicinal products. For new products, the data required for a Phase II ERA will need to be generated. For generic medicines, the client may have some of the necessary information and some data may already be available in the published literature.

At wca we have extensive experience in assisting both proprietary and generic pharmaceutical companies in conducting ERAs in support of their market authorisation applications for both new and existing products. Our pharmaceutical ERA services extend to:

• Evaluating whether, for generic or well established pharmaceuticals, a complete ERA is actually required

Phase I ERA

• Calculation of exposure estimates
• Evaluation of epidemiological data and refinement of the default market penetration factor, where applicable

Phase II ERA

• Review of existing company data and open literature data for use in Phase II
• Where data gaps are apparent we have the expertise to initiate and monitor environmental fate and effects studies on behalf of the client:
  • Obtain and compare quotes from Contract Research Organizations (CRO)
  • Advice on tiered testing; definition of testing programme
  • Study protocol review and agreement with CRO
  • Study monitoring
  • Peer review of draft study reports
• Preparation of Expert Report for submission in Module 1.6 of the dossier
• Post-submission support with authorities