Slovakia has introduced a new system for agreeing managed entry agreements that will make it easier for companies to get their innovative medicines to the market.
A new regulatory amendment now in force in Slovakia will make it easier for companies to strike managed entry agreements (MEAs) and therefore secure market access, according to the law firm Allen and Overy. The changes will also bring Slovakian regulations further into line with European standards, according to lawyers.
An amendment to Slovakia’s 2012 Reimbursement Act (Act No. 363/2011 Coll) came into force in August. “This is so far...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
