EMA’s advice confirms that the company’s planned CMC approach is well aligned with the requirements for the upcoming marketing authorization application. The agency clarified the expected supplementary data and considered the overall manufacturing strategy appropriate, further strengthening Cinclus Pharma’s regulatory readiness going forward.
 
“The feedback from EMA represents another important step in our progression. In October, we received similar input from the FDA regarding our CMC plans, and it is encouraging to see both agencies now providing consistent support for our strategy. This positive feedback reinforces the view that Cinclus Pharma is well positioned to advance linaprazan glurate toward the market in a safe and efficient manner,” says Christer Ahlberg.”, CEO of Cinclus Pharma.
 
CMC guidance is a central component of the regulatory process and ensures that manufacturing methods, quality systems, and control strategies meet regulatory standards. Early engagement with regulatory authorities enables companies to identify and address potential challenges in the development process.
 
Cinclus Pharma continues to advance its development activities according to plan and intends to maintain close dialogue with both EMA and FDA in the upcoming stages of the process.