EU Accelerated Assessment Tracker

Takeda's Dengue Vaccine Candidate Reverts To Standard Review Timelines

 
• By Maureen Kenny
  
Generate a summary of this article
Listen to this article
Beta

The EU marketing authorization application for Takeda's dengue vaccine candidate is no longer being fast-tracked. Also, four requests for accelerated assessment were decided on at the latest meeting of the European Medicines Agency's drug evaluation committee, the CHMP.

This tracker provides information on accelerated assessment requests for planned marketing authorization applications (MAAs) that have come before the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for a decision. It also tracks whether companies retain fast-track status for MAAs as they make their way through the EU centralized procedure.

Fast-track review can cut a few months off the approximately 12 months it generally takes to review an application under...

Pink Sheet Podcast

Learn what's happening at the US FDA. On the go.

Derrick Gingery and the team bring you a weekly "Drug Fix".

SpotifyApple PodcastsWebsite

More from Europe

EU Biosimilar Filings, Opinions And Approvals

 
• By Saba Afreen

<p>Executive Summary</p> <p>A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.</p>

EU Pharma Reform: What You Need to Know Now

 
• By Anabel Costa-Ferreira and Ian Schofield

As the reform of the EU pharmaceutical legislation progresses through the legislative process, the Pinks Sheet offers an infographic highlighting some of the key changes being proposed that will reshape the way drug companies run their business.

New EU Approvals

<p>Executive Summary<p> <p>The Pink Sheet's list of EU centralized approvals of new active substances has been updated to add six new products, incl/ding Ixchiq, Valneva's chikungunya virus vaccine</p>

More from Geography

Canada Cuts Red Tape With Single Ethics Review For Trials

A new research ethics review system for multi-site clinical trials in Canada is expected to help improve study start-up times, avoid unnecessary duplication and boost the country’s competitiveness on a global stage.

Nancy Test Circulable Section Geography

 
• By Brian Bossetta

This is a short description

Diversity Action Plans: What To Submit And When

 
• By Nielsen Hobbs

With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be implemented.