The rapporteur for the draft directive that is part of the proposed EU legislative revision package says the pharmaceutical industry needs certainty and long-term predictability regarding the expected level of regulatory data protection. But her proposal to increase the RDP period is not shared by the rapporteur for the draft regulation.
Fears that the European Commission’s proposed overhaul of the pharmaceutical legislation will have a tortuous journey through the EU legislative machinery appear well grounded after the two rapporteurs for the European Parliament’s environment and public health committee (ENVI) took very different positions in their draft reports on the revision package.
Pernille Weiss of the center-right European People’s Party, who is rapporteur for the draft directive – part of the commission’s...
<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.
