To accelerate the adoption of innovation in the global administration of the pharmaceutical industry, regulatory authorities and industry trade organizations must expand their scope and pursue a collaborative approach to recognition and reliance to streamline processes, enhance product quality, and improve patient access to medicines.
Pharmaceutical manufacturing is at a turning point. For decades, large-scale centralized facilities have been the backbone of medicine production, but today’s healthcare landscape demands something different: flexibility and personalization. Patients need therapies that are accessible anywhere, tailored to individual needs, and produced with resiliency against shortages. Emerging models like...
Advancements in technology—such as process intensification, continuous manufacturing, and 3D printing—are enabling transportable and point-of-care (PoC) medicines manufacturing, especially with the rise of personalized medicine. Modular, small-scale production systems are particularly well-suited for cell and gene therapies and other advanced therapy medicinal products (ATMPs) designed for...
ISPE’s Regulatory Quality Harmonization Committee (RQHC) is structured with four Regional Focus Groups (RFGs): Asia-Pacific, Europe/Middle East/Africa, Latin America, and North America. The RFGs support ISPE in its understanding and response to regulatory issues and concerns for the specific region. The RQHC Asia-Pacific RFG includes pharmaceutical professionals located in or having specific...
