The EU regulatory framework is adequate for electronic product information, although work to develop certain aspects is required, according to a pilot report published by the European Medicines Agency.
The EU is to work towards a phased implementation of electronic product information (ePI) following a successful pilot that looked at creating and testing ePI.
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The European Medicines Agency has recommended 16 drugs for EU-wide approval, including Vertex’s cystic fibrosis drug Alyftrek and five other orphans.
The European Medicines Agency’s assessments of applications for variations play a key role in supporting international regulatory reliance mechanisms. Companies can aid this by ensuring the scope of their post-approval changes is clear, and notifying the EMA when sharing reports with non-EU regulators.
Novo Nordisk’s application seeking EU marketing approval to use its GLP-1 receptor agonist to treat cirrhotic metabolic dysfunction-associated steatohepatitis is one of 15 new drug filings the European Medicines Agency has started reviewing. Meanwhile, Arrowhead’s filing for its familial chylomicronemia syndrome, plozasiran, is being fast tracked.
Nirogacestat was one of four products scheduled for an oral explanation meeting at the European Medicines Agency this week.
Pink Sheet reporter and editors discuss the most recent senior staff departures at the FDA and their impact on the agency, as well as Commissioner Martin Makary’s plans for a new approval pathway and a combined adverse event database as outlined in an interview with a podcast host.
The European Medicines Agency has recommended 16 drugs for EU-wide approval, including Vertex’s cystic fibrosis drug Alyftrek and five other orphans.
The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.
