Regulatory Acceptance

One challenge to adoption is the regulatory acceptance of new alternative evidence generation methods as developed by ToxHQ.

We are currently participating actively in case study development activities, such as the Read Across and Adverse Outcome Pathway (AOP) risk assessment activities on SEURAT and EUToxRisk, led by industry and regulatory representatives.

We have lead the international collaboration activities on data analysis between SEURAT and Tox21 and interact closely with regulators such as the US EPA, US FDA, EcHA, EC-JRC and OECD. Such activities are ensuring that the ToxHQ solutions are closely matching to emerging industry and regulatory requirements for verification, validation and acceptance.

We carry our case study work specifically designed with validation and regulatory goals, in collaboration with Safer Medicines Trust (SMT), and involving regulators including the US FDA and US EPA. The study provides the opportunity to transfer drug knowledge to health and environmental goals of other sectors while also advancing the societal goal of safer medicines. For example, drug compound pairs can provide a convincing test of predictions, based on known observed human adverse effects.