Our September/October issue focuses on regulatory trends and quality initiatives. ISPE is continually striving to enhance our regulatory engagement efforts. We recognize the importance of regulatory affairs and continue to build and strengthen our relationships with health authorities on behalf of our members.
ISPE Regulatory Affairs Overview
With more than 2,200 ISPE members from regulatory authorities representing 76 countries, ISPE has a strong regulatory presence. In 2024, ISPE secured 96 regulatory speakers across 23 events, more than 350 regulatory attendees from 44 countries, and regulatory reviews of seven ISPE Guidance Documents.
Our 17 Regulatory Volunteer Groups work to strengthen relationships and collaborative efforts with global regulatory authorities. In 2024, 290 members contributed to more than 50 conference sessions, articles, blog posts, and more. They also provided expert input on 12 documents released for consultation.
Members of ISPE’s committees, working groups, and initiatives are involved in training activities with health authorities to support the implementation of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines. For example, in April, ISPE provided training to Health Canada on implementing ICH Q11.
Key ISPE Regulatory and Quality Initiatives
ISPE’s Enabling Pharmaceutical Innovation Program
This program promotes global harmonization of regulatory guidelines to improve patient access to innovative medicines and technologies. In response to regulatory interest, ISPE has shared case studies highlighting industry challenges and continues to engage with health authorities to support alignment. Over the past decade, inconsistent interpretation of ICH guidelines across regions has hindered innovation in manufacturing and continuous improvement. Learn more in the article “Delivering for Patients Through Harmonization: Insights from Five Global Innovation Case Studies,” in this issue.
ISPE’s Advancing Pharmaceutical Quality (APQ) Program
This program helps organizations assess and improve their quality management maturity (QMM) using practical tools aligned with global standards and priorities of the US Food and Drug Administration (FDA). The program supports global quality excellence and aligns with the US FDA’s focus on QMM to assess and rate the maturity of manufacturing facilities. The ISPE APQ Guide Series covers key areas like change management, Corrective Action and Pre-ventive Action (CAPA) systems, management responsibilities and review, performance and product quality monitoring systems, and cultural excellence. ISPE also offers a training course based on the guide series. Looking ahead, ISPE is developing a Quality Risk Management (QRM) maturity assessment tool in collaboration with APQ, drug shortages, and QRM teams, expected in 2026.
ISPE’s PQLI® Initiative
This initiative started as a way to help bring the ICH quality guidelines to life—making them practical and actionable for the industry. It focuses on key concepts from ICH Q8 through Q12 to support product quality throughout its lifecycle, with the goal of driving continuous improvement.
ISPE’s PQLI® technical teams are developing solutions to help the pharmaceutical industry keep up with changing regulations and scientific advancements. Specifically, they’re focused on areas like Chemistry, Manufacturing, and Controls (CMC) and Good Manufacturing Practices (GMP). By developing new approaches in these areas, the teams aim to help companies maintain high product quality and stay compliant with evolving global standards. Learn more by visiting Product Quality Lifecycle Implementation (PQLI) ®.
ISPE provides on-demand, self-paced training covering ICH Guidelines 6–10, supporting education in pharmaceutical development and manufacturing. For details, visit ISPE.org/training. To learn more about ISPE’s regulatory and quality initiatives, visit ISPE Regulatory Operations.
