ISPE is committed to fostering communications and interactions to advance common interests among the pharmaceutical industry and regulatory agencies.
Innovating Regulation: Global Perspectives on Modernizing Quality and GMP
The pharmaceutical industry is rapidly transforming through digitalization, AI, advanced manufacturing, and sustainability pressures. Regulators must modernize frameworks, harmonize globally, and enable science-based oversight while supporting innovation and access to medicines. At the 2026 ISPE European Annual Conference, regulators from Europe and the U.S. discussed priorities, bottlenecks, and proactive strategies to prepare regulatory systems for next-generation pharmaceutical technologies. READ MORE
Reimagining Regulatory Operations in the AI Age
Artificial intelligence is rapidly becoming embedded in medicines regulation, evolving from pilot use to a core capability across Europe’s regulatory network. The EMA and HMA have launched multi-year AI and data strategies through 2028, supported by emerging guidance on AI and large language models. Dr. Hilmar Hamann of EMA highlighted how AI will shape development, governance, and trust throughout the medicinal product lifecycle. READ MORE
From Manual to Modern: FDA's View on 25 Years of Aseptic Processing
Aseptic processing has evolved significantly since the 1990s, shifting from manual, operator-intensive processes to more advanced, controlled systems. At the 2026 ISPE Aseptic Conference, FDA’s Rick Friedman reflected on this transformation, noting improvements in sterility assurance and manufacturing practices. He also identified ongoing gaps where the industry still falls short, offering insights on maintaining quality and advancing sterile drug production practices. READ MORE
Streamlining the Path to Drug Supply Resilience in the US
Drug shortages continue to impact patients despite ongoing efforts. A new approach focuses on using FDA data, aligning incentives, and streamlining oversight to strengthen supply resilience. By rewarding high-performing manufacturers and prioritizing critical medicines, stakeholders can drive quality and reliability. ISPE highlights how collaboration, modernization, and smarter regulatory strategies can help ensure consistent access to essential therapies when patients need them most. READ MORE
Learn more about ISPE’s Drug Shortages Initiative.
ISPE input to Draft Guidance, Regulations, and Consultation Documents
ISPE comments on proposed regulations and guidance that affect the bio/pharmaceutical industry. Comments are solicited from ISPE Communities of Practice (COPs), Committees, Councils, Task Teams, and Members-at-large.
For more information, contact Carol Winfield, Sr. Director Regulatory Operations, ISPE.