Certara Simcyp® Simulator Becomes First and Only Software Platform to Receive EMA Qualification Opinion for PBPK Modeling
Certara (NYSE:CERT) has achieved a significant regulatory milestone as its Simcyp® Simulator becomes the first and only software platform to receive European Medicines Agency (EMA) qualification for PBPK modeling in regulatory submissions across the EU.
The qualification, following a multi-year collaboration with EMA, enables pharmaceutical companies to use Simcyp Simulator for assessing drug-drug interaction (DDI) risk in regulatory submissions without re-establishing the platform's credibility. The qualification covers 3 context-of-use scenarios spanning 6 CYP enzymes and 2 inhibition mechanisms, potentially reducing the number of required clinical studies.
Certara (NYSE:CERT) ha raggiunto un importante traguardo regolatorio: il suo Simcyp® Simulator è diventato la prima e unica piattaforma software ad ottenere la qualificazione dall'Agenzia Europea per i Medicinali (EMA) per la modellizzazione PBPK nelle submission regolatorie in tutta l'UE.
Questa qualificazione, frutto di una collaborazione pluriennale con l'EMA, permette alle aziende farmaceutiche di utilizzare il Simcyp Simulator per valutare il rischio di interazioni farmacologiche (DDI) nelle submission regolatorie senza dover nuovamente dimostrare l'affidabilità della piattaforma. La qualificazione copre 3 scenari di contesto d'uso che includono 6 enzimi CYP e 2 meccanismi di inibizione, con il potenziale di ridurre il numero di studi clinici necessari.
Certara (NYSE:CERT) ha alcanzado un hito regulatorio significativo, ya que su Simcyp® Simulator se convierte en la primera y única plataforma de software en recibir la cualificación de la Agencia Europea de Medicamentos (EMA) para modelado PBPK en presentaciones regulatorias en toda la UE.
La cualificación, tras una colaboración de varios años con la EMA, permite a las compañías farmacéuticas usar Simcyp Simulator para evaluar el riesgo de interacciones medicamentosas (DDI) en presentaciones regulatorias sin necesidad de revalidar la credibilidad de la plataforma. La cualificación abarca 3 escenarios de contexto de uso que cubren 6 enzimas CYP y 2 mecanismos de inhibición, lo que podría reducir el número de estudios clínicos requeridos.
Certara (NYSE:CERT)는 중요한 규제 이정표를 달성했습니다. 자사의 Simcyp® Simulator가 유럽의약품청(EMA)으로부터 유럽 연합 내 규제 제출을 위한 PBPK 모델링에 대해 최초이자 유일한 소프트웨어 플랫폼으로서 자격을 부여받았습니다.
EMA와의 다년간 협력 끝에 획득한 이번 자격 부여는 제약사들이 Simcyp Simulator를 사용해 규제 제출 시 약물 간 상호작용(DDI) 위험을 평가할 때 플랫폼의 신뢰성을 재확립할 필요 없이 활용할 수 있게 합니다. 이 자격은 3가지 사용 맥락 시나리오와 6가지 CYP 효소 및 2가지 억제 메커니즘을 포함하며, 임상 시험 수를 줄일 가능성이 있습니다.
Certara (NYSE:CERT) a franchi une étape réglementaire majeure avec son Simcyp® Simulator, devenu la première et unique plateforme logicielle à obtenir la qualification de l'Agence européenne des médicaments (EMA) pour la modélisation PBPK dans les dossiers réglementaires à travers l'UE.
Cette qualification, fruit d'une collaboration de plusieurs années avec l'EMA, permet aux entreprises pharmaceutiques d'utiliser le Simcyp Simulator pour évaluer le risque d'interactions médicamenteuses (DDI) dans les dossiers réglementaires sans avoir à rétablir la crédibilité de la plateforme. La qualification couvre 3 scénarios d'utilisation incluant 6 enzymes CYP et 2 mécanismes d'inhibition, ce qui pourrait réduire le nombre d'études cliniques nécessaires.
Certara (NYSE:CERT) hat einen bedeutenden regulatorischen Meilenstein erreicht, da sein Simcyp® Simulator die erste und einzige Softwareplattform ist, die von der Europäischen Arzneimittelagentur (EMA) für PBPK-Modellierung in regulatorischen Einreichungen in der gesamten EU qualifiziert wurde.
Die Qualifizierung, die nach einer mehrjährigen Zusammenarbeit mit der EMA erfolgte, ermöglicht es Pharmaunternehmen, den Simcyp Simulator zur Bewertung des Risikos von Arzneimittelwechselwirkungen (DDI) in regulatorischen Einreichungen zu verwenden, ohne die Glaubwürdigkeit der Plattform erneut nachweisen zu müssen. Die Qualifizierung umfasst 3 Nutzungskontext-Szenarien mit 6 CYP-Enzymen und 2 Inhibitionsmechanismen und könnte die Anzahl der erforderlichen klinischen Studien reduzieren.
- First and only software platform to receive EMA qualification for PBPK modeling
- Streamlines drug submission process across EU by eliminating need to re-establish platform credibility
- Reduces required number of clinical drug-drug interaction studies for pharmaceutical companies
- Covers broad range of applications with 6 CYP enzymes and 2 inhibition mechanisms
- None.
Insights
Certara's Simcyp Simulator receives landmark EMA qualification, creating significant competitive advantage in drug development simulation market.
Certara's achievement of EMA qualification for its Simcyp Simulator represents a significant regulatory milestone in the pharmaceutical industry. This is the first-ever qualification granted by the EMA for a physiologically-based pharmacokinetic (PBPK) modeling platform, positioning Certara with a substantial competitive advantage in the biosimulation market.
The qualification specifically enables pharmaceutical companies to use Simcyp for drug-drug interaction (DDI) risk assessment in EU regulatory submissions without needing to validate the platform's credibility each time. This covers 3 context-of-use scenarios across 6 CYP enzymes and 2 inhibition mechanisms—significantly reducing the clinical studies sponsors must conduct.
From a regulatory perspective, this development aligns with the industry's shift toward model-informed drug development (MIDD), where computational models replace certain clinical studies. For Certara's clients, this translates to faster regulatory submissions, reduced development costs, and potentially accelerated time-to-market for new drugs.
The multi-year collaborative process with EMA regulators to achieve this qualification underscores the scientific validity of Certara's platform. As regulatory bodies increasingly accept simulation-based evidence, Certara's first-mover advantage in this space could strengthen its market position and potentially expand its customer base among pharmaceutical developers looking to streamline their regulatory submission processes.
RADNOR, Pa., Aug. 04, 2025 (GLOBE NEWSWIRE) -- Certara, Inc., a global leader in biosimulation, today announced that the European Medicines Agency (EMA) has formally qualified the Simcyp® Simulator for use in regulatory submissions across the EU. Certara is the first company to receive EMA qualification for a PBPK modeling platform, and Simcyp is the only software to hold this designation. The recognition follows a rigorous multi-year, collaborative engagement between Certara and the EMA.
With this qualification in place, sponsors can now use the Simcyp Simulator 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. Simcyp has long been the leading biosimulation software used in submissions to the EU and other regulatory agencies, and this qualification makes the drug submission process easier and faster. “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,” said William F Feehery, Chief Executive Officer. “This milestone reflects the value of Certara’s scientific leadership, innovation, and technical expertise.”
Drug-drug interaction (DDI) studies typically involve the co-administration of two or more drugs, where one acts as a substrate and the other as a perpetrator. The qualification opinion covers various scenarios (3 COUs) where Simcyp simulations can replace clinical DDI studies using a range of verified substrates and perpetrators integrated within the platform. The COUs span 6 CYP enzymes and 2 inhibition mechanisms, thereby significantly reducing the number of clinical studies a sponsor has to conduct.
“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,” said Rob Asbury, President, Certara Predictive Technologies. “This is yet another exciting stepping stone as we continue to empower drug developers to utilize mechanistic modeling to speed decision making, further scientific insights, and bring innovative medicines to patients faster.”
To learn more about the Simcyp Simulator and how it supports MIDD strategies, visit www.certara.com/simcyp.
About Certara
Certara accelerates medicines using biosimulation software, technology, and services to transform traditional drug discovery and development. Its clients include more than 2,400 biopharmaceutical companies, academic institutions, and regulatory agencies across 70 countries. Learn more at certara.com.
Certara contact:
Sheila Rocchio
Sheila.rocchio@certara.com
Media contact:
Alyssa Horowitz
certara@pancomm.com
FAQ
What is the significance of Certara's EMA qualification for the Simcyp Simulator?
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What types of drug interactions can be assessed with Certara's Simcyp Simulator?
When did Certara receive the EMA qualification for Simcyp Simulator?
