Efforts to harmonize the notification and communication requirements for drug shortages in the EU will take a step forward this month when regulators adopt a common definition of a shortage together with a number of guidance documents. The situation with regard to drug shortages has been called a public health emergency.
Later this month, EU regulators expect to take a major step forward in their drive to harmonize the way that member states deal with supply chain interruptions and non-marketing of authorized medicines. Among other things, they are hoping to adopt a common definition of what constitutes a medicine shortage.
The EU task force that is looking into the causes of shortages and how to address them will issue a...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
