Environmental risk assessment for medicinal product

Client

A pharmaceutical product development company.

Background

An environmental risk assessment (ERA) was required for national marketing authorisation of a medicinal product, according to Article 8 of EU Directive 2001/83/EC.

Project goals

Bibra, in partnership with an expert environmental consultancy, were requested to conduct an ERA in accordance with EMA guidance and justify that the use of the drug poses no significant risk to the environment.

Approach

A Predicted Environmental Concentration in surface water (PECSW) was calculated for one breakdown product of the drug in accordance with EMA guidelines, and data were identified on its natural occurrence (i.e. levels in freshwater systems). These values were compared to illustrate the negligible increase in environmental levels following use of the drug product. Also relevant ecotoxicity information were considered for the two primary breakdown products.

Project outcome

Bibra and its expert partner completed the ERA, with a robust data package which justified how the use of the drug product poses no risk to the environment.

Project Team

Charles Johnson

Richard Young

 

Pharmaceuticals

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