The forthcoming overhaul of the EU pharma legislation should not include an expansion of the hospital exemption provision for advanced therapies, warn industry and regulators.
Rather than increasing access to medicines, expanding the hospital exemption provision for advanced therapy medicinal products (ATMPs) as part of the European Commission’s pharmaceutical legislative overhaul could make industry less inclined to launch such products in the EU.
This warning was issued by speakers at a recent symposium hosted by the Alliance For Regenerative Medicines (ARM), which represents...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
