European regulators are working with global partners to tackle challenges that sponsors face during “N-of-1” trials, where medicines are personalized to the individual, and looking at the regulation of platform technologies.
Support for companies developing medicines for rare diseases is built into EU legislation through the Orphan Regulation, but these incentives are not always suitable for products that are being developed for very rare diseases or patient-specific treatments, experts from the European Medicines Agency and European Commission have heard.
During an interactive EMA webinar on orphan drug R&D and regulation in the EU, several officials from the EMA and...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
