ARTICLE

Key Regulatory Changes in the EU for 2025

The European Union has implemented significant regulatory changes in 2025 aimed at enhancing drug safety and efficacy. Key updates include stricter guidelines on clinical trial transparency and an emphasis on post-market surveillance...

REGULATORY · FDA

CGMP Compliance Trends

Over 90% of recent FDA CGMP inspections found facilities in acceptable compliance. The FDA continues to prioritize risk-based inspections, focusing on facilities with historical compliance issues.

REGULATORY · FDA

New Guidance on High-Risk Components

In May 2023, the FDA issued guidance requiring immediate testing of high-risk components such as glycerin for diethylene glycol and ethylene glycol. This guidance remains critical for manufacturers...

REGULATORY · FDA

Postmarket Surveillance Inspections

The FDA conducts postmarket surveillance inspections based on risk factors without prior indication of quality issues. This proactive approach aims to ensure ongoing compliance in the market.

MANUFACTURING · APAC

Regulatory Harmonization Efforts

APAC countries are increasingly focusing on harmonizing regulatory standards to facilitate smoother drug approvals. This trend is expected to enhance collaboration among member states.

MANUFACTURING · APAC

Increased Focus on Quality Management

Regulatory bodies in APAC are emphasizing the importance of quality management systems in pharmaceutical manufacturing, aligning with global standards.

MANUFACTURING · APAC

Emerging Markets and Compliance Challenges

Emerging markets in APAC face unique compliance challenges due to varying regulatory frameworks. Companies must navigate these complexities to ensure market access.