The European Medicines Agency is keen to highlight its landmark policy on proactive publication of clinical data but it’s aware of the challenges involved in this and other transparency initiatives.
Regulators and drug companies have to be prepared for the challenges that are likely to come from the increasing involvement of civil society in matters relating to drug evaluation, according to the second-in-command at the European Medicines Agency. It may backfire, the EMA’s deputy executive director, Noel Wathion, told a conference. “We have to be realistic,” he said.
Civil society at large is no longer satisfied with knowing only the outcome of the scientific review process or with...
<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>
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.
<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>
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.
With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be implemented.
