Quality Systems

Articles

The agency has received certification with the Eco-Management and Audit Scheme for its commitment to environmental sustainability.

EMA Earns EMAS Certification

The platform is live with full functionality for use by marketing authorization holders and national competent authorities to report drug supply information.

European Drug Shortage Monitoring Platform Fully Operational

The HTAR, which aims to increase access to new medicines, becomes effective Jan. 12, 2025.

EMA Prepared for Health Technology Assessment Regulation Implementation

Felicity Thomas is Associate Editorial Director of Pharmaceutical Technology, Pharmaceutical Technology Europe, BioPharm International.

Videos

Pharmaceutical Technology chats about continuous processes and regulatory considerations for processing equipment with Christian Dunne from ChargePoint Technology.

Using Continuous Processes and Automation to Remove Contamination Risk

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

Protection of Personal Data in European Medicine Regulation

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

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

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

Electronic Product Information Moves Forward in Europe

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

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

Feliza Mirasol is the science editor for 

The European Commission has approved Novo Holdings' acquisition of Catalent, which includes the related sale of three manufacturing sites to Novo Nordisk, which is also acquiring the Czech Republic manufacturing site of Novavax for $200 million.

Novo Nordisk Gains Manufacturing Sites from Novo Holdings and Novavax while EC Approves Catalent Acquisition

A new platform allowing market authorization holders to report drug shortages has gone live. 

Regulatory/GMP Compliance, Europe