Companies can have their EU centralized marketing authorization application and submission for an Article 58 opinion (on medicines for use in non-EU countries) reviewed in parallel by the European Medicines Agency. The simultaneous assessment can be helpful when drugs and vaccines are needed for both EU and non-EU populations.
The European Medicines Agency is offering companies the possibility to apply for the parallel assessment of medicines or vaccines meant for the EU-wide market as well as for non-EU countries under the so-called Article 58 procedure.
The simultaneous assessment of EU centralized marketing authorization applications (MAAs) and Article 58 submissions, the EMA explained, will help optimize...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
