EU Procedures for Medicinal Product Authorization and Supervision

The European Parliament has proposed a regulation to standardize the authorization and supervision of medicinal products for human use. This includes new rules for the European Medicines Agency (EMA) and updates to existing regulations.

Key areas covered:

• Managing and preventing medicinal product shortages
• Reporting and detecting shortages
• Inspections and compliance measures
• Roles of the European Commission and Member States
• EMA’s responsibility in identifying critical products and monitoring shortages
• Protection of commercially confidential information
• Data security and compliance with health data regulations

The regulation aims to enhance patient safety, improve supply chain security, and ensure compliance with EU data protection standards.

Source: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:C_202501329

Region: European Union