C-Path’s History with EMA and Qualification

In 2004, FDA and EMA laid the groundwork for joint-agency biomarker reviews when they developed a framework called the Voluntary Exploratory Data Submission review process, which allowed public-private partnerships (PPPs) such as C-Path to submit a single biomarker data application to both regulatory agencies, and then to meet jointly with scientists from both agencies to discuss it in detail and to address additional scientific questions posed by the regulators. Each regulatory agency would then review the application separately and make independent decisions on use of the new biomarkers.

In 2007, C-Path’s Predictive Safety Testing Consortium (PSTC) became the first consortium to utilize this process, when it submitted biomarker data applications for seven nonclinical kidney safety biomarkers. Merck & Co., a PSTC member in the United States, and Novartis AG, a European member of the PSTC, identified the new biomarkers, tested them to prove their accuracy and usefulness, and then shared their findings with the other consortium members for further study. The consortium then submitted applications for use of the biomarkers to FDA and EMA.

In May 2008, EMA issued a qualification statement for these nephrotoxicity biomarkers. It was the first of several EMA qualifications C-Path has achieved to date.

 

C-Path has also received EMA qualifications or letters of support for:

 

C-Path not only engages with EMA in the formal submission process for regulatory qualification, but many of its consortia regularly interact with EMA for scientific advice and informed opinions concerning novel methodologies as well. In addition, C-Path has participated in or co-sponsored numerous workshops with EMA, including:

 

Programs utilizing EMA scientific advice/opinion completed or underway:

 

 

 
  • Model-based clinical trial enrichment platform for clinical trials in PD (scientific advice meeting, April 2018)