News dal mondo

10

Ago

EMA issues updated guidance on shortage prevention plans ahead of legal deadline

The European Medicines Agency (EMA) has issued an updated guideline to assist marketing authorisation holders (MAHs) to create and maintain drug shortage prevention plans (SPPs) for their products.

MAHs must submit these plans to national competent authorities upon request and are required to implement them by mid-2027 under the new EU pharmaceutical legislation.

The agency explained that the goal of the SPPs is to identify vulnerabilities within medicine supply chains and ensure that appropriate measures are in place to prevent, mitigate, or manage any risks that could lead to shortages...[EMA - RAPS]

18

Set

EU Biotech ACT - Ue in ritardo sui farmaci biotech, sempre più ampio il gap con USA

È quanto emerso in un incontro svolto nei giorni scorsi a Bruxelles tra alcuni parlamentari europei...

18

Set

Innovation & Pharma: The Molecules & Companies

How truly innovative is the bio/pharma industry? What products, modalities, and companies are behind...

18

Set

US FDA Launches Pilot To Expedite INDs

FDA has launched a pilot program to expedite review of investigational new drug (IND) filings with applications...