EMA Explains Process For Assessing Suitability Of Biomarkers With Concerned Medicines

A new EU guideline outlines the steps that notified bodies can take to facilitate the European Medicines Agency’s assessment of the appropriateness of a companion diagnostic’s use with a drug.

Liquid Biopsy Technology Concept - Early Detection of Cancer Through Circulating DNA Mutations - Innovative Cancer Screening Technology - Innovation in Oncology - 3D Illustration
IVD Regulation makes it mandatory for companion diagnostics to undergo a conformity assessment by a notified body • Source: Shutterstock

The European Medicines Agency has issued final guidance outlining the procedure that notified bodies designated to review in vitro diagnostics (IVDs) must follow when seeking a scientific opinion on the suitability of a companion diagnostic (CDx) with the concerned medicinal product.

The guideline is expected to further support the development of CDxs or biomarkers that are a critical tool for furthering personalized medicine as they can help match a patient to a specific drug or therapy by predicting a likely response or severe toxicity

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Europe

Spain Slashes Wait Between EU Drug Authorization And Financing Decisions

 

Spanish authorities say that that timelines for drug reimbursement decisions can be improved further with the right submissions from companies.

Spain Beats England To Tevimbra Reimbursement Recommendations

 

Spanish authorities have published more pricing and reimbursement reports as part of a new drive to increase transparency.

Commission Taking ‘Due Account’ Of Scathing Report On EU Clinical Trial Bottlenecks

 
• By 

A report by the European pharmaceutical industry criticizes the EU’s clinical trials framework, highlighting regulatory fragmentation, inefficiencies and the need for targeted reforms.

EU Moment Of Truth For Obe-Cel And 10 Other New Medicines

 

Autolus’s CAR T therapy obe-cel is among the medicines that are this week due for an opinion by the European Medicines Agency on whether they should be marketed in the EU.

More from Geography

Spain Slashes Wait Between EU Drug Authorization And Financing Decisions

 

Spanish authorities say that that timelines for drug reimbursement decisions can be improved further with the right submissions from companies.

Spain Beats England To Tevimbra Reimbursement Recommendations

 

Spanish authorities have published more pricing and reimbursement reports as part of a new drive to increase transparency.

Commission Taking ‘Due Account’ Of Scathing Report On EU Clinical Trial Bottlenecks

 
• By 

A report by the European pharmaceutical industry criticizes the EU’s clinical trials framework, highlighting regulatory fragmentation, inefficiencies and the need for targeted reforms.