US-based biosimulation software company Certara Inc. (NASDAQ:CERT) announced on Monday that the European Medicines Agency (EMA) has officially qualified the Simcyp Simulator for use in regulatory submissions throughout the European Union, making Certara the first company to receive such recognition for a physiologically-based pharmacokinetic (PBPK) modelling platform.

Following an extensive, multi-year collaboration with Certara, the EMA qualification means that drug developers can now use Simcyp to assess drug-drug interaction risk in EU submissions without needing to reconfirm its credibility for approved contexts.

The qualification covers three specific context of use (COU) scenarios involving simulations of drug-drug interactions using a range of verified substrates and perpetrators integrated within the platform. The COUs cover six CYP enzymes and two inhibition mechanisms, reducing the need for certain clinical studies to be conducted and thereby streamlining the drug approval process.