Environmental risk assessment for human pharmaceuticals New developments
By Dr. Ulrich Memmert, Eurofins Regulatory AG*, UlrichMemmert@eurofins.com
*: Affairs Group
An Environmental Risk Assessment (ERA) is required for marketing authorisation of Human Medicinal Products by the European Medicines Agency (EMA) since 2006. This affects all new products (with some exemption like vitamins, amino acids, peptides, electrolytes, and herbal products) but also existing drugs if e.g. a new indication results in significant increase in their extent of use.
During the past few years, several important questions arose on how to interpret some sections of the present ERA Guideline EMEA/CHMP/SWP/4447. For this reason, a Question and Answer (Q&A) document (EMA/CHMP/SWP/44609/2010) was finalised by EMA in 2011. Experience shows that with the implementation of the Q&A document, the ERA requirements were more strictly interpreted. For example, marketing research and prediction data cannot be further used for the refinement of the market penetration factor Fpen. Fpen can only be refined on the basis of European disease prevalence data when published by a reliable and independent source, e.g. a peer-reviewed scientific journal or the World Health Organisation (WHO).
Also other potential risk factors became more spotlighted. One of them is the PBT (persistent, bioaccumulative and toxic) assessment for drug substances. Others are the need for identification of degradation products in environmental studies, or the indication that the drug substance may have endocrine activity in the environment. Expertise is needed for the evaluation of available study results or for planning of study programmes to address these potential risks and for discussions with Competent Authorities.
Eurofins Regulatory AG in Switzerland has gained profiency and expertise in these areas in recent years. Several wellexperienced experts are offering support for the environmental risk assessment, including project management and study monitoring, as well as expert judgement for e.g. PBT assessment for potential endocrine disrupting activity. Also data gap analysis, literature search and peer review of scientific literature are performed for the ERA of existing drugs. All environmental studies can be conducted at Eurofins laboratories. For more information on Eurofins' full range of services, including environmental studies and consulting work for the environmental risk assessment.
Visit www.eurofins.com.
Contact: GMP_EU@eurofins.com
