2010
● MHRA Has Been Rejecting One-Third of Type IA Variation Notifications Due to Information Shortcomings
2011
● CMC/GMP Procedures and Interpretations Can Pose Challenges for Foreign Firms in ICH Member Japan
● ICH Q11 Draft Gelling on Lifecycle/Change Management and Control Strategy Components
2012
2013
2014
● Post-Approval Change Regulatory Burden Draws Heat at Japan Biotech CMC Strategy Forum
● Global Quality Regulatory Maze Jeopardizes Vaccine Supply, IFPMA is Stressing
● FDA and EMA Finalize Guidances to Help in Post-approval Change Management
2015
2016
● Industry/Regulator Dialogue on Knowledge Management is Intensifying in Wake of ICH’s Q12 Initiative
2017
● FDA’s Office of Pharmaceutical Quality Advances Review/Inspection Integration
2018
● Pharma is Exploring How to Maximize ICH Q12 Value in Practice; Q12 EWG Encourages Feedback
● Role of Established Conditions Drawing Attention in Global Dialogue on ICH Q12’s Potential
2019
● KASA and PQ/CMC Initiatives Gain Momentum in FDA’s Efforts to Strengthen Quality Review Process
2020
2021
● Pandemic Intensifies USP’s Focus on Supply Chain Vulnerabilities and Vaccine Development