EU regulators have produced the first fruits of their ambitious “big data” project aimed at ensuring that the EU drug regulatory system can make full use of the rapidly increasing volume and complexity of data being gathered across multiple settings in the healthcare area.
Big data will play a key role in regulatory procedures for developing, evaluating and monitoring the safety and effectiveness of medicines, medical devices and combinations of the two, and without it many future regulatory activities will not be possible.
However, many hurdles must still be overcome in areas like data access, transfer, interoperability and quality, and without a coordinated...
<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>
The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.
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.
