Certara's Simcyp Simulator Receives EMA Qualification for PBPK Modeling

Certara's Simcyp Simulator has become the first and only software platform to receive European Medicines Agency (EMA) qualification for PBPK modeling. This recognition allows sponsors to use the platform in regulatory submissions across the EU to assess drug-drug interaction risk without re-establishing credibility. The qualification covers various scenarios and significantly reduces the number of clinical studies required.

Certara, Inc., a global leader in biosimulation, has achieved a significant milestone with the European Medicines Agency (EMA) qualifying its Simcyp® Simulator for use in regulatory submissions across the EU. This recognition marks the first and only software platform to receive such qualification for physiologically-based pharmacokinetic (PBPK) modeling [1]. The qualification allows sponsors to assess drug-drug interaction (DDI) risk without needing to re-establish the platform's credibility for each regulatory submission [2].

The EMA qualification covers three context-of-use scenarios (COUs) that span six CYP enzymes and two inhibition mechanisms, significantly reducing the number of clinical studies required. This development aligns with the industry's shift towards model-informed drug development (MIDD), where computational models replace certain clinical studies [2].

The qualification is a result of a rigorous, multi-year collaborative engagement between Certara and the EMA. This collaboration underscores the scientific validity of Certara's platform and positions it with a substantial competitive advantage in the biosimulation market [1].

From a regulatory perspective, this development simplifies the drug submission process, potentially reducing development costs and accelerating time-to-market for new drugs. As regulatory bodies increasingly accept simulation-based evidence, Certara's first-mover advantage could strengthen its market position and expand its customer base among pharmaceutical developers seeking to streamline their regulatory submission processes [2].

References:
[1] https://www.streetinsider.com/Globe+Newswire/Certara+Simcyp%C2%AE+Simulator+Becomes+First+and+Only+Software+Platform+to+Receive+EMA+Qualification+Opinion+for+PBPK+Modeling/25138406.html
[2] https://www.stocktitan.net/news/CERT/certara-simcyp-simulator-becomes-first-and-only-software-platform-to-xvfac7y2o45k.html