July 22, 2024

While many eyes are on events in the US this week, there’s lots going on in Europe that bears paying attention to (even outside the soccer, tennis, Olympic and bicycle events!). As you likely know, European politicians and agency officials are determined to address the issue of Europe being a beacon of innovation and specifically an attractive space for innovation in the biopharma development ecosystem.?

The Accelerating Clinical Trials in the European Union initiative, known as ACT EU, is sponsored by the European Commission, the European Medicines Agency and the Heads of Medicines Agency and started in 2022. With several priority action areas, the work done under this umbrella intends to provide improved overall architecture for the clinical trial landscape in Europe. Accomplishments so far include, but are not limited to, optimizing and iterating the Clinical Trial Information System (CTIS) functionality, driving implementation and possible iteration of the Clinical Trial Regulation, updating GCP guidelines for decentralized trials, and connections to important efforts such as the COMBINE project. It’s worth staying aware and informed on ACT EU news and events - such as this notice on the new version of CTIS.?

Additionally, you should be aware that EMA announced it will more strictly apply existing CHMP guidance on granting clock-stop extensions for license applications starting this month. There will therefore be fewer clock-stop extensions.?

This is due to EMA announcing they will now strictly? apply their 2009 Guideline. A strong justification will be necessary in any clock-stop extension request, no extensions will go beyond 6 months, and clock-stops will not be granted to solve problems known prior to the submission (especially if flagged in an EMA pre-submission meeting). Similar to the ACT EU initiative, this clock-stop strict adherance change is in response to feedback and challenges with long EMA review times.

What books are you reading this summer? I recently finished Kara Swisher’s Burn Book, A Tech Love Story and I recommend it for a behind the scenes dive into the work of tech. I also enjoy her podcasts Pivot and On.?

Wishing everyone a good week and stay cool if it’s summer where you live!

Michelle