REGULATORY · EMA

EMA's 2026 Programming Document

The EMA has outlined its strategic focus for 2026-2028, emphasizing preparation for new pharmaceutical rules and enhancing support for rapid authorizations.

REGULATORY · EMA

New EU GMP Guidelines

The updated EU GMP guidelines for Part I and Part II are set to enhance quality assurance in manufacturing, aligning with international standards.

REGULATORY · EMA

Monitoring of Critical Medicines

The EMA will oversee critical medicines through a dedicated group to mitigate shortages and ensure consistent supply across the EU.

ARTICLE

Key changes in EU pharmaceutical legislation for 2026

The European Union has enacted significant reforms in pharmaceutical legislation effective January 2026. These changes include a reduction in exclusivity periods, now contingent on genuine market presence across all Member States. Notably...

MANUFACTURING · EDQM

Quality Control for Packaging Lines

The EDQM has proposed that manufacturers implement monitoring systems for packaging lines to ensure compliance with quality standards for hospital-scannable barcodes.

MANUFACTURING

Regulatory Compliance for Parallel Traders

New regulations require parallel traders to include both originator batch numbers and repackaging codes in EU repositories to enhance traceability.