Luxembourg’s new regulator will work to attract investment and improve public health as well as tackle the growing problem of drug shortages.
Luxembourg is to create its own medicines and healthcare products regulatory agency after the government approved a bill to this effect at the end of 2019. The ALMPS (Agence Luxembourgeoise des Médicaments et des Produits de Santé) will help deal with the growing problem of medicine shortages; it is also hoped it will bring in further investment.
Luxembourg is one of a small number of European countries that does not have its own medicines agency.
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
