Columns | View from Brussels

EU proposal focuses on a subset of underserved rare diseases—exploring the gaps in those conditions for which there is no approved treatment option.

With lessons from COVID now established, concrete ideas on improving drug development strategy for future health threats are beginning to take shape.

EU’s sweeping push for major pharma reforms to impact the daily practice of clinical trials community.

Dissecting the EMA’s new annual report on milestones reached in clinical research and public health.

Grading the government’s formal response to reform efforts hopeful of boosting UK’s sagging global standing in drug development.

EMA operated-Priority Medicines scheme receives update which will expedite response to applicants.

The hopes for increased transparency in clinical research beginning to take shape as sponsors get up to speed with new reporting obligations.

Europe trade and lobby group says implementation issues related to the legislation could impact 420 trials—and 42,200 patients—over the next three years.

Latest project centers on partnership to align PM innovation with sustainable healthcare.

Reformed EMA looks to tackle challenges in drug development, pediatric medicines, and unmet medical need.

The Association of the British Pharmaceutical Industry greets the development with mix of relief and urgency.

EMA opens public discussion on envisioned platform to encourage multi-stakeholder interactions and shared understanding.

The issues engulfing compliance with the Clinical Trials Regulation signal that even the best intentions with these types of laws may not be enough to avert unintended consequences.

WHO in midst of forming group focused on developing guidance on best practices in clinical trials.

With compliance deadline at end of month, concerns over readiness remain.

Despite agreement on recommendations between European regulators, DCT unclarity remains.

Debates caught between focusing on existing antibiotics and developing new agents.

The Sudan Ebola virus outbreak in Uganda spotlights this dilemma in responding to public health crises.

Inaugural group of members added to EMA’s new data network focused on RWE.

New guidance to drill down on more specifics in hopes of harnessing the growth of these types of studies.

Rare disease stakeholders speak out ahead of anticipated EU changes.

Smoothing path to CTIS compliance will be key in overall effort to transform clinical trials in Europe.

New EU clinical trial regulation places heavy importance on patient-submitted documents.

The hope is to build a formal framework for using digital health technology in clinical trials in Europe and beyond.

Proposed US merger could threaten innovation in cancer diagnosis, Commission officials assert.

Commission pushes for a “more unified” approach to drug development following a period of fragmented coordination during the pandemic.

Orientation pursuits hit high gear as formal rule compliance inches closer.

Newly unveiled workplan focuses on harnessing the impact of big data on drug development—and ultimately public health.

The scope of RWE’s use in developing and approving new medicines is pitting key healthcare stakeholders against each other.

Payers join the push for better demonstrations of efficacy of new medicines.