Issue 23: Pharmaceutical regulatory roundup

BY DR TIM SANDLE  | 30 July 2024

Catch up with the latest news from around the pharmaceutical industry with issue 23 of our regulatory review, curated by Dr Tim Sandle.

Environmental risk assessment of medicinal products for human use - scientific guideline

The European Medicines Agency (EMA) has issued a new guidance for conducting environmental risk assessments for pharmaceuticals.

It is mandatory for a Marketing Authorisation Application (MAA) for a medicinal product for human use (HMP) to include an Environmental Risk Assessment (ERA). This ERA is based on the use of the product and the physico-chemical, ecotoxicological and fate properties of its active substance(s).