In the effort to enable realisation of the Council for Harmonisation (ICH) Quality Vision established in 2003, which is to “develop a harmonised pharmaceutical quality system applicable across the lifecycle of the product emphasizing an integrated approach to quality risk management and science”, ICH have developed the following Quality Guidelines: ICH Q8/11, 9 and 10, and thereafter the draft ICH Q12 guideline that addresses the technical and regulatory considerations for pharmaceutical product lifecycle management. ICH Q8/11, 9 and 10 provide high-level direction with respect to the scope and definition of “Quality-by-Design”(QbD), following the concept that quality should be designed into a product. ICH Q12 provides a framework to facilitate the management of post-approval CMC changes in a  more predictable and efficient manner. The shift towards conceptual framework guidelines has become increasingly important given the dynamic nature of the pharmaceutical industry, including complex global pharmaceutical supply chains, and more product diversity and innovation. The 2-day ICH workshop on ICH Q8/11, 9, 10 and 12 guidelines strives to foster a better understanding of this new quality paradigm and to address the potential challenges in their implementation in the ASEAN and greater Asia-Pacific region.