ISPE Regulatory Digest Q1 2024

ISPE is committed to fostering communications and interactions to advance common interests among the pharmaceutical industry and regulatory agencies.

Quality Beyond CGMP: FDA Initiatives

Understanding the Challenges in Drug Shortages

In a keynote presentation at ISPE’s 2024 Facilities of the Future Conference, Carla J. Lundi, US FDA, spoke about the critical role of quality surveillance in ensuring the availability of quality medicines for all patients, and highlighted the benefits of advanced manufacturing and Quality Management Maturity. 


Advancing Digitalization in Manufacturing: EU Initiatives

A presentation by Evdokia Korakianiti, EMA, at ISPE’s 2023 Annex 1 and Pharma 4.0 Conference outlined strategies taken by the EMA to ensure new and innovative technologies are adopted without compromising the availability and quality of medicines. 


Evdokia Korakianiti

Regulators Discuss AI and its Effects on Regulatory Issues

Practical Applications of Current Standards and Regulations in the Context of Digitalization

The panel discussion focused on the practical applications of current standards and regulations in the context of digitalization. The panelists included regulators from AEMPS, EMA, and the US FDA who discussed AI’s effect on manufacturing and control and on the industry. 


Regulatory Challenges and Reform in Asia-Pacific

In the Republic of Korea, recent changes in registering – and maintaining – a regulatory dossier could delay the approval of new drug products or implementation of key changes. In China, aligning the regulatory framework with ICH initiated a period of dynamic regulatory reform that continues to this day. 


Asia Pacific Region Map - Image by Freepik

ISPE Comments on Draft Guidance and Regulations

ISPE recently submitted comments on:

ISPE Regulatory Volunteers in the News

We are pleased to showcase recent interviews with members of the ISPE community. 

Ben Stevens, Director of CMC Policy and Advocacy at GSK and member of the ISPE Q12 Implementation Team, recently shared his insights on change management practices and protocols during an interview. 


Diane Hustead, Executive Director, Regulatory Affairs, Merck & Co., Inc., and current chair of the ISPE Drug Shortages Initiative Team, provided insights into risk assessment and the ISPE Drug Shortages Prevention Model during her recent interview. 


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