With the EU pharmaceutical legislation due to undergo a radical shake-up to create a future-proof regulatory system, the time is ripe for industry to engage with efforts to make the European drug approval process more agile.
The upcoming review of the EU pharmaceutical legislation is the ideal opportunity for drug companies to address any concerns they might have about the pace of medicine approvals in Europe compared with other jurisdictions, a senior EU regulatory official has suggested.
While the real-time assessment of COVID-19 vaccines and treatments by regulators worldwide has raised industry expectations, Anthony Humphreys of the...
<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.
