Changes To EU Pharma Reform: More Questions Than Answers?

 
• By Ian Schofield
  
Generate a summary of this article
Listen to this article
Beta

In the first of a series of articles on the future direction of the EU pharmaceutical reform proposals, the Pink Sheet looks at the new uncertainties created for the drug industry after the European Parliament voted through a series of amendments in the area of regulatory data protection.

Fuzzy man walking on hanging bridge vanishing in fog. Focus on middle of bridge.
Uncertainties lie ahead for the EU pharma reform • Source: Shutterstock

The proposed reform of the EU pharmaceutical legislation passed a major hurdle after it was OKd by the European Parliament earlier this month, but there is still a long way to go before it is approved by the member states and finally adopted.

Key Takeaways

  • Talks on the pharma overhaul between the European Parliament and Council are likely to be protracted, with some lawyers predicting it will be 2028 before the new legislation is implemented.

Given the likelihood of continuing disagreement over key issues such as regulatory data protection (RDP) periods, some legal experts are...

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

Quotable: Top Experts On Policy Hot Topics

 
• By Anabel Costa-Ferreira

The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.

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