Columns | View from Brussels

Largely discarded topic beginning to grab hold in policy discussions.

Battle lines being drawn among key healthcare constituencies, as discussions around new approaches to drug evaluation and decision-making heat up.

The reporting of one man in Europe is changing accountability with compliance.

But despite showing a tightening of focus on clinical trials and evidence, the annual report doesn’t paint the full picture.

EMA’s new release factors in scientific advances, clarity on trial designs.

Just-released analysis by Prescrire contends that the agency “is backtracking on commitments to clinical data transparency.”

EMA continues to familiarize industry with new clinical trial legislation.

‘Independence’ the priority for the longstanding European Organization for Research and Treatment of Cancer, Winette van der Graaf tells Applied Clinical Trials in interview.

Stress the importance of clinical studies today—and urge for formal approach to managing the pandemic and addressing specific public health needs more sustainably.

ICH draft guideline advocating a more comprehensive framework in optimizing pediatric drug development reaches next step.

What to make of UK’s draft resolution set for review on the international stage.

Leaked draft gives glimpse into potential new research proposals as part of the EU’s Horizon program.

Agency report reveals solid results from the first five years of its PRIME scheme, but also calls for improvements in focus.

Organization says either reform European drug development rules—or lose out on global competition.

EU’s new health innovation center unveils several projects focused on advancing R&D, medical countermeasures, and related technologies.

2022 EU initiative provides hope for improvement of trial regulations.

EMA officially launches coordination center to systemize data analysis and real-world interrogation.

New EU guidance now officially in effect.

New guidance looks to streamline safety assessment process.

The European Union is reaching out for independent experts to help advise on its health development programs in needy areas of regulatory science.

The Innovative Health Initiative is expected to launch its first call for proposals early this year.

Object lessons in implementing next-generation sequencing in cancer diagnosis in Europe.

Pressure grows for advances in drug development.

Increased public engagement leads recent change in EMA profile.

The European Union has at last agreed on how HTA should be coordinated among Europe's multiple HTA agencies, bringing to an end a three-year process of discussion.

European authorities have announced a proposal for a framework to support not-for-profit organizations and academia in repurposing authorized medicines.

A new straw has appeared in the wind that may mean something more substantial will emerge than the customary rhetoric...

A proposal to address inequities in access to critical COVID vaccine commodities is still deadlocked a year after it was submitted.

The EU is offering some $13 million for advice on bringing to the market medicines that combat antimicrobial resistance—and there's only one month to claim the grant...and then nine to do the work.

Pandemic sparks new advancements in clinical trial development.