In an exclusive interview with the Pink Sheet, the European Medicines Agency’s Tony Humphreys explains the thinking behind the agency’s regulatory science strategy, why the PRIME scheme is to get a boost – and why the need to tackle health threats ranked so low in a stakeholder consultation.
First Brexit, then coronavirus. For an organization like the European Medicines Agency, sitting at the hub of a huge and complex EU drug regulatory network, it is hard to think of a more disruptive succession of events.
Forced out of its London home by the UK’s decision to leave the EU, the EMA relocated to temporary premises...
<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.
