Certara Simcyp庐 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庐 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庐 Simulator 猫 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'affidabilit脿 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庐 Simulator se convierte en la primera y 煤nica plataforma de software en recibir la cualificaci贸n de la Agencia Europea de Medicamentos (EMA) para modelado PBPK en presentaciones regulatorias en toda la UE.
La cualificaci贸n, tras una colaboraci贸n de varios a帽os con la EMA, permite a las compa帽铆as farmac茅uticas usar Simcyp Simulator para evaluar el riesgo de interacciones medicamentosas (DDI) en presentaciones regulatorias sin necesidad de revalidar la credibilidad de la plataforma. La cualificaci贸n abarca 3 escenarios de contexto de uso que cubren 6 enzimas CYP y 2 mecanismos de inhibici贸n, lo que podr铆a reducir el n煤mero de estudios cl铆nicos requeridos.
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EMA鞕赌鞚� 雼る厔臧� 順戨牓 雭濎棎 須嶋摑頃� 鞚措矆 鞛愱博 攵�鞐姅 鞝滌暯靷摛鞚� Simcyp Simulator毳� 靷毄頃� 攴滌牅 鞝滌稖 鞁� 鞎诫 臧� 靸來樃鞛戩毄(DDI) 鞙勴棙鞚� 韽夑皜頃� 霑� 頂岆灚韽检潣 鞁犽靹膘潉 鞛檿毽巾暊 頃勳殧 鞐嗢澊 頇滌毄頃� 靾� 鞛堦矊 頃╇媹雼�. 鞚� 鞛愱博鞚� 3臧�歆� 靷毄 毵ル澖 鞁滊倶毽槫鞕赌 6臧�歆� CYP 須唽 氚� 2臧�歆� 鞏奠牅 氅旍护雼堨鞚� 韽暔頃橂┌, 鞛勳儊 鞁滍棙 靾橂ゼ 欷勳澕 臧�電レ劚鞚� 鞛堨姷雼堧嫟.
Certara (NYSE:CERT) a franchi une 茅tape r茅glementaire majeure avec son Simcyp庐 Simulator, devenu la premi猫re et unique plateforme logicielle 脿 obtenir la qualification de l'Agence europ茅enne des m茅dicaments (EMA) pour la mod茅lisation PBPK dans les dossiers r茅glementaires 脿 travers l'UE.
Cette qualification, fruit d'une collaboration de plusieurs ann茅es avec l'EMA, permet aux entreprises pharmaceutiques d'utiliser le Simcyp Simulator pour 茅valuer le risque d'interactions m茅dicamenteuses (DDI) dans les dossiers r茅glementaires sans avoir 脿 r茅tablir la cr茅dibilit茅 de la plateforme. La qualification couvre 3 sc茅narios d'utilisation incluant 6 enzymes CYP et 2 m茅canismes d'inhibition, ce qui pourrait r茅duire le nombre d'茅tudes cliniques n茅cessaires.
Certara (NYSE:CERT) hat einen bedeutenden regulatorischen Meilenstein erreicht, da sein Simcyp庐 Simulator die erste und einzige Softwareplattform ist, die von der Europ盲ischen Arzneimittelagentur (EMA) f眉r PBPK-Modellierung in regulatorischen Einreichungen in der gesamten EU qualifiziert wurde.
Die Qualifizierung, die nach einer mehrj盲hrigen Zusammenarbeit mit der EMA erfolgte, erm枚glicht es Pharmaunternehmen, den Simcyp Simulator zur Bewertung des Risikos von Arzneimittelwechselwirkungen (DDI) in regulatorischen Einreichungen zu verwenden, ohne die Glaubw眉rdigkeit der Plattform erneut nachweisen zu m眉ssen. Die Qualifizierung umfasst 3 Nutzungskontext-Szenarien mit 6 CYP-Enzymen und 2 Inhibitionsmechanismen und k枚nnte 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鈥攕ignificantly 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庐 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鈥檚 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. 鈥淭his first of its kind qualification by EMA regulators of a new approach methodology further demonstrates the scientific value biosimulation provides to drug development scientists,鈥� said William F Feehery, Chief Executive Officer. 鈥淭his milestone reflects the value of Certara鈥檚 scientific leadership, innovation, and technical expertise.鈥�
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聽clinical聽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.
鈥淲e鈥檙e 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鈥檝e been working towards for聽numerous years,鈥� said Rob Asbury, President, Certara Predictive Technologies. 鈥淭his 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.鈥�
To learn more about the Simcyp Simulator and how it supports MIDD strategies, visit .
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
Media contact:
Alyssa Horowitz
FAQ
What is the significance of Certara's EMA qualification for the Simcyp Simulator?
How will Certara's Simcyp EMA qualification impact drug development?
What types of drug interactions can be assessed with Certara's Simcyp Simulator?
When did Certara receive the EMA qualification for Simcyp Simulator?
