The revised version of the Guideline for the Environmental Risk Assessment (ERA) of medicinal products comes into force on 1 September 2024.
This will result in numerous changes/innovations, e.g. with regard to test strategies to be applied (e.g. antibiotic substances), the assessment of possible secondary poisoning and the methodology. The revised version was a long time coming with initial concepts dating back to 2016.
At the same time, the revision of EU pharmaceutical legislation will result in numerous tightening measures with regard to the assessment of environmental risks posed by medicinal products. The reform of pharmaceutical legislation is intended to support the objectives of the Green Deal, which calls for a transformation of the economy and society towards greater environmental protection and sustainability. The Green Deal calls for a reduction of 50% in plastic waste and 30% in microplastics in the environment, 50% in the use of pesticides and 50% in the use of antibiotics in animals by 2030.
With regard to the risks associated with the use of medicinal products, the proposed Medicinal Products Directive takes into account undesirable effects of the medicinal product on the environment (Art. 4(35)) and the derivation of a risk-benefit ratio of a positive therapeutic effect of the medicinal product in relation to possible environmental risks (Art. 4(41)). This means that environmental aspects can lead to the rejection of an authorisation.
Article 22 also states that other EU legislation relevant to the ERA must be taken into account. Furthermore, the CLP Regulation ((EC) No. 1272/2008) Annex I is to be applied with regard to the classification of the medicinal product, one of its ingredients or other components as PBT, vPvB, PMT or vPvM.
The consequences of the forthcoming revision of the environmental assessment on the authorisation of AMs are not yet foreseeable. The study requirements are becoming more complex, the studies are expensive and lengthy. With the limited number of test facilities, there are probably not enough slots available for conducting them.
ACA-pharma concept GmbH regularly carries out environmental risk assessments and also offers corresponding training seminars.
