REGULATORY · EMA

EMA Expands Clinical Data Publication Policy

Starting April 2025, the EMA will expand its Clinical Data Publication Policy to include all new MAAs, line extensions, and major clinical Type II variations. This change aims...

REGULATORY · EMA

Revised Variations Regulation to Take Effect

The revised Variations Regulation (EU) 2024/1701 will apply to EMA variation applications starting January 1, 2025, streamlining the process for regulatory changes.

REGULATORY · EMA

New EU Pharmaceutical Legislation Expected in 2026

The European Parliament and Council have reached a political agreement on new pharmaceutical legislation reform, which is expected to be adopted and come into force in 2026.

ARTICLE

Key Changes in EU Pharmaceutical Regulations

As of January 1, 2025, the EU Falsified Medicines Directive (FMD) will no longer apply in Northern Ireland. This change mandates that safety features will be governed by UK law. Manufacturers must...

NEWS

FDA CGMP Compliance Updates

The FDA continues to emphasize the importance of Current Good Manufacturing Practice (CGMP) compliance. Recent inspections highlight the need for stringent adherence to quality standards.

NEWS

Impact of CGMP on Market Access

Compliance with CGMP is critical for market access in the US. Companies must ensure that their manufacturing processes meet FDA standards to avoid delays in product approvals.

NEWS

Trends in FDA Inspections

Recent trends in FDA inspections indicate a focus on data integrity and quality management systems, urging manufacturers to enhance their compliance frameworks.