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Impact of the new ERA guidance on the conduction of Pharmacokinetic and Toxicity studies

By March 15, 2024March 18th, 2024No Comments

We are pleased to share the poster our colleague Arno Wess presented at EUROTOX in 2019

Title: “Impact of the new ERA guidance on the conduction of Pharmacokineticand Toxicity studies

The environmental risk assessment (ERA) is a requirement for the registration of a Human Medicinal Product (HMP) as module 1.6 in the (electronic) Common Technical Document ((e) CTD) format. Although a dossier can be rejected if the ERA lacks, the outcome of it cannot be a reason for denial of the Market Authorisation Application (MAA).

On 15 November 2018 the European Medicines Agency has released a draft revision of the guideline on the ERA of medicinal products for human use (EMA 2018) for public consultation. The current guideline (EMEA 2006) describes a tiered testing strategy recommended for the evaluation process. In addition, there is a Questions and Answer (Q&A) document (EMA 2016). An explaining commentary from authors working at various European authorities is available (Whom sley et al. 2019). It highlights mayor changes, whereat some are effectively already implemented based on the Q&A document (EMA 2016) or may differ more structurally such as the assessment for Persistence, Bioaccumulation and Toxicity (PBT), which is in the flow diagram placed as a process to be followed in parallel.