Switzerland’s medicines agency has cleared Ferring’s carbetocin for preventing uterine haemorrhage under the Marketing Authorization for Global Health Products (MAGHP) procedure, which is intended to accelerate the approval of new products in low- and middle-income countries.
A new procedure for speeding access to essential medicines in low and middle income countries (LMICs) has produced its first fruit after the Swiss regulator issued a marketing authorization for a drug from Ferring used in the prevention of uterine haemorrhage.
Ferring described the approval as a landmark. The company will now submit its dossier to national regulatory authorities (NRAs) in...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
