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December 18, 2023
The Multi-annual AI Workplan creates a strategy to maximize the benefits and manage the risks of artificial intelligence.
December 13, 2023
Regulators in the European Union have published the first version a list of critical medicines in the EU to avoid potential shortages.
December 02, 2023
What does the 2024 VPAS mean for pharma?
November 09, 2023
Electronic product information for selected human medicines that have been harmonized across the European Union have been published for the first time.
November 03, 2023
The EC is calling for interested parties for their safety and orphan drug committees.
November 02, 2023
A novel approach for safety assessments in inhalation drugs may avoid animal testing for drug products.
The EU’s AI Act is set to become the world’s first comprehensive legal framework for artificial intelligence.
October 25, 2023
The agency’s solidarity mechanism allows Member States to support each other when there is a shortage of a critical medicines.
October 20, 2023
The designation will grant Lisata EU marketing exclusivity for 10 years after approval and protocol assistance from EMA.
October 18, 2023
The agency is warning patients and healthcare providers about pre-filled pens falsely labeled as Ozempic.