Latest Regulatory & Industry Updates — November 2025

Insights curated by GLORAMP Pharma Consulting Ltd
Stay informed with the most recent developments from leading global authorities — EMA, MHRA, FDA, CMDh, and EDQM — plus key regulatory shifts affecting pharmaceutical operations, pharmacovigilance, quality systems, eTMF management, and QP batch release.

🌍 Global Regulatory Spotlight: Harmonisation and Efficiency

1. EU: Streamlining Lifecycle Management and Emergency Preparedness

The European Medicines Agency (EMA) and the European Commission (EC) have been highly active, pushing for greater efficiency and readiness.

• Updated Variations Guidelines: Following the new Variations Regulation effective January 2025, the EC released updated Variations Guidelines. This reform aims to speed up approval timelines for post-approval changes by simplifying the classification of variations (Type IA, IB, II) and promoting predictability. Companies must integrate these new risk-based classification principles into their regulatory lifecycle planning.
• Accelerating Development in Health Emergencies: The EMA’s Emergency Task Force (ETF) issued new guidance to improve scientific advice and accelerate regulatory processes, particularly for products against public health threats like antimicrobial resistance (AMR). This includes a rapid scientific advice review timeline of just 20 days in emergencies.
• PRIME Scheme Update: The PRIME (Priority Medicines) scheme, which offers early and proactive support for medicines addressing unmet medical needs, was updated. The focus remains on generating robust data early in development to enable accelerated assessment.

2. ICH: Assembly Meeting and Global Alignment

The International Council for Harmonisation (ICH) Assembly met in Singapore in November 2025, reinforcing its commitment to global standards.

• ICH continues its work on technical requirements to ensure safe, effective, and high-quality medicines globally. Companies should closely monitor the output of the various Working Parties to anticipate upcoming guideline finalisations.