Global Regulatory Pathways for Drugs and Biologics

Catalog description

This course provides a comprehensive overview of regulatory requirements and pathways for the development, approval, and commercialization of drugs and biologics (including biosimilars) outside the United States. The focus will be on key global markets including the European Union, India, Japan, and the broader Asia-Pacific region. Students will explore region-specific regulatory frameworks such as the European Medicines Agency (EMA) centralized procedure, India's CDSCO processes, Japan’s PMDA review system, and regulatory trends in countries such as the China NMPA, South Korea MFDS, and Australia TGA. The course will examine critical topics such as clinical trial authorization, marketing application requirements, quality and manufacturing compliance, pharmacovigilance obligations, and so-called reliance pathways to speed market access and reduce duplication of effort. Global concurrent regulatory submissions are now no longer just a want, but an imperative business need. Emphasis will be placed on strategic considerations for global development programs, including multi-regional clinical trials, harmonization efforts through ICH guidelines and differences that can impact timelines, costs, and market access. Designed for students and professionals entering regulatory affairs or global drug development, this course equips learners with the foundational knowledge to navigate and manage regulatory activities in major ex-U.S. jurisdictions.