EU Legislative Reform

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.

Those working in the medtech sector returned from their traditional August break to a growing sense that the EU is more collectively aligned about the need to improve the medtech regulations and soon.

High unmet needs is among the terms and definitions in the EU’s regulatory reform package that are “very subjective” and require more clarity to improve predictability for the pharmaceutical industry, EUCOPE’s secretary general, Alexander Natz, tells the Pink Sheet.

So far, calls for much needed changes to the medtech regulatory system have focused on the Medical Device Regulation. Don’t neglect the IVD Regulation, industry says.

The new European Commissioners will face a grilling from members of the European Parliament before they can be confirmed in their posts.

The commission's recently reelected president also wants the new commission to evaluate the need for potential changes to the medtech regulations.

Reflecting on 40 years of EU medtech regulation makes me realize how incredibly far we have come. But have we come full circle and replaced the frustrations of four decades ago with a different, but equally challenging, set of problems?

Centralization and rationalization of the EU’s medtech rules are critical, particularly for conformity assessment and clinical evidence. Hear the views of Tom Melvin and Erik Vollebregt first-hand in a new in-depth interview on regulatory problems and opportunities.

Now European businesses are returning to “normal” after the summer break, they will find key developments have occurred in the EU during the traditional holiday season.

A draft declaration to be presented to the UN General Assembly in September suggests that a “lack of regulation of over-the-counter use of antimicrobials” is one of the “drivers of antimicrobial resistance.” Industry, however, insists that misuse and over-prescription of antibiotics are the primary drivers of AMR, and is advocating for the text to be amended accordingly.