Regulatory/GMP Compliance, Europe

Bringing Collaboration to the Horizon Once More

January 03, 2024

UK scientists are once again able to participate in the Horizon European research programme thanks to a deal struck in 2023.

Finalizing the European Health Data Space

January 02, 2024

The EHDS aims to increase access to health data, but how will it impact pharma?

European Medicines Regulatory Network on Track to Meet Goals

December 27, 2023

The midterm report of the European Medicines Agencies Network Strategy finds that the network has strengthened and is on track to achieve its objectives.

EMA Publishes Guide for Use of AI in Medicine Regulation

December 18, 2023

The Multi-annual AI Workplan creates a strategy to maximize the benefits and manage the risks of artificial intelligence.

List of Critical Medicines Published in EU

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.

Renewing the UK Voluntary Pricing Scheme

December 02, 2023

What does the 2024 VPAS mean for pharma?

Europe Publishes Electronic Product Information for Selected Medicines

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.

European Commission Searches for Committee Experts

November 03, 2023

The EC is calling for interested parties for their safety and orphan drug committees.

Breathing Easier

November 02, 2023

A novel approach for safety assessments in inhalation drugs may avoid animal testing for drug products.

The EU AI Act

November 02, 2023

The EU’s AI Act is set to become the world’s first comprehensive legal framework for artificial intelligence.