Revised guidelines published by EMA and HMA update the rules on identification of commercially confidential information and personal data used in marketing authorization applications.

Innovation, Collaboration, and Performance Were Highlights for EMA in 2024

By Susan Haigney

December 24th 2024

Emer Cooke, executive director of EMA, is encouraged by the competitiveness of the European pharmaceutical market.

Electronic Product Information Moves Forward in Europe

By Susan Haigney

December 17th 2024

A pilot program to explore creation and testing of ePIs in regulatory procedures shows positive results.

Several Orphan Drugs Among Medicines Recommended for Approval by EMA in December

By Susan Haigney

December 16th 2024

EMA recommended 17 drugs for marketing authorization in December, including treatments for rare heart conditions, anemia, and liver disease.

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