Certara's Simcyp Simulator Becomes First PBPK Modeling Platform to Receive EMA Qualification for EU Regulatory Submissions
核心洞察
Certara's Simcyp Simulator (搜索) has become the first and only PBPK modeling platform to receive formal qualification from the European Medicines Agency (搜索) for regulatory submissions across the EU.
The qualification allows sponsors to use Simcyp simulations to assess drug-drug interaction risk in regulatory submissions without re-establishing the platform's credibility for specified scenarios.
The qualification covers three contexts of use spanning six CYP enzymes (搜索) and two inhibition mechanisms, potentially reducing the number of required clinical DDI studies.
Certara, Inc. announced that the European Medicines Agency (搜索) (EMA) has formally qualified the Simcyp® Simulator for use in regulatory submissions across the EU, marking the first time any company has received EMA qualification for a physiologically-based pharmacokinetic (PBPK) modeling platform. The recognition follows a rigorous multi-year, collaborative engagement between Certara and the EMA.
Regulatory Milestone for Biosimulation
With this qualification in place, pharmaceutical sponsors can now use the Simcyp Simulator (搜索) in regulatory submissions across the EU to assess drug-drug interaction (DDI) risk without needing to re-establish the platform's credibility for the specified context of use (COU) scenarios. According to William F Feehery, Chief Executive Officer, "This first of its kind qualification by EMA regulators of a new approach methodology further demonstrates the scientific value biosimulation provides to drug development scientists."
The qualification makes the drug submission process easier and faster, building on Simcyp's established position as the leading biosimulation software used in submissions to the EU and other regulatory agencies.
Clinical Study Reduction Potential
Drug-drug interaction studies typically involve the co-administration of two or more drugs, where one acts as a substrate and the other as a perpetrator. The EMA qualification opinion covers various scenarios across three COUs where Simcyp simulations can replace clinical DDI studies using a range of verified substrates and perpetrators integrated within the platform.
The COUs span six CYP enzymes (搜索) and two inhibition mechanisms, thereby significantly reducing the number of clinical studies a sponsor has to conduct. This represents a substantial efficiency gain for pharmaceutical companies developing new therapies.
Industry Transformation
Rob Asbury, President of Certara Predictive Technologies, emphasized the broader implications: "We're at an inflection point in drug development as the industry and regulators increasingly prioritize model-informed drug development (MIDD). This recognition and regulatory trust from the EMA further solidify the future we've been working towards for numerous years."
The qualification represents another step toward empowering drug developers to utilize mechanistic modeling to speed decision making, further scientific insights, and bring innovative medicines to patients faster.
Company Profile
Certara accelerates medicines using biosimulation software, technology, and services to transform traditional drug discovery and development. The company serves more than 2,400 biopharmaceutical companies, academic institutions, and regulatory agencies across 70 countries, positioning it as a global leader in biosimulation technology.