Supply Chain & Sustainability Pressures

European authorities are tightening requirements around medicine availability and environmental sustainability.

What This Means for You:

• Incorporate supply-risk assessments into regulatory dossiers and QMS.
• QP teams should document sustainability and supply continuity in batch release records.
• Review distribution and storage GDP compliance for climate impact.

Introduction: 

EU pharma industry expectate new regulations changes in the year 2025. European Medicines Agency (EMA) and other regulatory authorities in the continent gradually increase regulatory requirements that exercise greater pressure on business entities to implement patient-oriented, sustainable, and innovative production standards.

Based on the presented list of compliance topics, let’s consider key compliance issues, effective measures for pharma companies, and helpful tools for compliance management.