EU pharmaceutical legislation ensures the authorisation of safe, effective and high-quality medicinal products. One aim of the current revision of EU pharmaceutical legislation is to improve the environmental safety of medicinal products. Stricter requirements for the environmental impact assessment when authorising medicinal products means that potential adverse effects on the environment and public health must be assessed and limited. The scope of the environmental risk assessment will be extended to include new protection goals such as the risks of antimicrobial resistance.

An environmental risk assessment with risk mitigation measures is required for the authorisation of medicinal products in the European Union. This environmental risk assessment (ERA) is anchored in Module 1.6 of the authorisation dossier.

On 1 September 2024, a new guideline (EMEA/CHMP/SWP/4447/00 Rev. 1) will come into force, which illustrates the procedure for an ERA using a flow chart (see below). The individual phases of an ERA are explained in detail in the guideline.

A systematic and targeted database search for ERA-relevant endpoints is mandatory in order to identify any information on the ecotoxicology of the active substance of the medicinal product. This information must be assessed for relevance according to a standardised method.

Our services

We support you in the creation of an ERA for medicinal products for human use by means of:

• Systematic and targeted database research
• Standardised evaluation of the extracted data for relevance (according to the CRED method)
• Compilation of all relevant ecotoxicological data on physicochemical properties, behaviour in the environment and in wastewater treatment plants, aquatic and sediment toxicity for the preparation of a data gap analysis
• Development of a testing strategy for missing data
• Planning and monitoring of studies, the studies are carried out in experienced partner laboratories/testing institutes
• Creation of module 1.6
• Enquiries to authorities/processing of responses from authorities or notifications of deficiencies
• Scientific and regulatory advice

We would be happy to support you in creating module 1.6. Contact us for more information:

Bianca Leubner
Phone: +49 (0) 341 223 292 36
email

Environmental risk assessment of medicinal products for human use