October 17, 2019 by Becky Brown
The assessment of the risks of pharmaceuticals in the environment is one of wca’s core work areas. We cover a range of activities from waiver statements through to bespoke one-off assessment and advocacy work.
A summary of some of our recent work in this area is highlighted here:
European Medicine Agency (EMA) Environmental Risk Assessments (ERA)
wca routinely conduct Phase I and II ERAs for pharmaceuticals to EMA guidelines1,2. Examples of recent successes include:
- Tier A assessment for a new antibiotic;
- A full risk assessment including Tier B terrestrial testing in support of registering a pharmaceutical with surfactant properties;
- Tier B refinement (SimpleTreat modelling) of an existing risk assessment for a generic product which otherwise would have required risk management.
Endocrine active substances
wca have expertise in this area with our expert assessors also being involved in endocrine disrupter assessments for other substances. In fact, wca have recently conducted a full endocrine disrupter assessment to EFSA/ECHA (2018)3 guidance for a biocide which also has some pharmacological activity. Our relevant experience related to endocrine testing for pharmaceuticals was highlighted in a recent blog.
We provide environmental foresight for the pharmaceutical industry. As part of this activity we keep abreast of global scientific and regulatory developments related to the environmental risks of pharmaceuticals. As such I recently participated in a workshop on the impact of pharmaceuticals in the environment in low- and middle-income countries. Also look out for Grace Panter at the forthcoming Royal Society of Chemistry meeting on antibiotics in the environment.
Increasing awareness of PiE has led to some companies taking an active approach to managing the impact of their products post-authorisation. wca offer an Eco-Pharmacovigilance service which is tailored to a company’s specific needs, but which typically involves literature searching to gather relevant fate and effects data, data reliability assessments and updating risk assessments where required.
Pharmaceutical industry groups (e.g. the Pharmaceutical Supply Chain Initiative) are encouraging best practice across the industry for safe discharge of pharmaceuticals during manufacturing. We are working with companies to help them manage the discharge of pharmaceuticals (and other process chemicals) to the environment using available data to derive Predicted No Effect Concentrations (PNEC) and safe discharge limits.
If you are interested in any of the above activities and would like further information or help with your risk assessments, please don’t hesitate to contact us.
1 EMA. 2006. Guideline on the environmental risk assessment of medicinal products for human use. Committee for Medicinal Products for Human Use (CHMP), European Medicines Agency (EMA), London, UK. MEA/CHMP/SWP/4447/00. 1 June 2006
2 EMA. 2016. Questions and answers on “Guideline on the environmental risk assessment of medicinal products for human use”. Committee for Medicinal Products for Human Use (CHMP), European Medicines Agency (EMA), London, UK. EMA/CHMP/SWP/44609/2010 Rev. 1. 26 May 2016
3 EFSA/ECHA. 2018. Guidance for the identification of endocrine disruptors in the context of regulations EU) No 528/2012 and (EC) No 1107/2009