EU Pharma Reform Amendments: More Shortage Reporting Obligations For Companies & Regulators

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

In the third of a series of articles on the European Parliament’s changes to the planned reform of EU pharmaceutical legislation, the Pink Sheet looks at how the amended proposals on notifying drug shortages could impact companies, regulators and wholesale distributors.

The EU is making efforts to keep pharmacy shelves full • Source: Shutterstock

Pharmaceutical companies and wholesalers will have to meet more requirements in terms of reporting medicine supply disruptions, and there will be a greater focus on the use of joint procurement in the event of shortages, if amendments made to the EU pharma reform by the European Parliament last month are backed by the member states.

Key Takeaways

  • The European Parliament wants manufacturers and wholesalers to meet additional requirements for notifying drug shortages.

There would be a greater role for the European Medicines Agency, its Medicines Shortages Steering Group (MSSG) and the EU...

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