Environmental risk assessment of active pharmaceutical

Client

A pharmaceutical product development company

Background

Following MHRA feedback on a previous Marketing Authorisation submission, our client required generation of a new environmental risk assessment (ERA) for a paediatric drug product.

Project goals

The first stage of an ERA is to calculate the predicted environmental concentration in surface waters (PECsw) of the drug (Phase I of EMA guidance). To search for, identify, and summarise relevant information on the likely environmental exposure to the intended marketed product and to refine the PECsw value appropriately.

Approach

Relevant data were identified on the fraction of the UK paediatric population that are likely to be administered the drug product (based on robust NHS statistics) and the maximum exposures were determined. Using this information the PECsw value was calculated and refined (according to EMA guidance) and the approach fully justified and documented in a bibra report co-authored by a partner consultancy expert in environmental assessments.

Project outcome

Bibra and its expert partner successfully completed Phase I of the ERA with a comprehensive justification for the method used in calculation of the PECsw. As the PECsw was found to be lower than the EMA ‘action limit,’ a Phase II ERA was not deemed necessary (saving the coming significant time and financial resources).

Project Team

Charles Johnson

Richard Young

• Environmental risk assessment for medicinal product
• All
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