James McCormick
James McCormick is a Senior Director within Regulatory affairs and, with more than 40 years of experience in Research and Development, he supports clients across the full spectrum of regulatory development. He mentors staff and clients with the delivery of their development strategies and maximisation of the global market.
James is TOPRA President-Elect 2026.
EditorialAsia-Pacific: A changing regulatory landscape
This issue explores the evolving regulatory landscape across Asia-Pacific, from China’s regulatory reforms and India’s digital and device initiatives to Australia’s evolving pathways and Japan’s gene therapy framework. With a focus on innovation, harmonisation, market access and implementation, it highlights the practical challenges and opportunities shaping regulatory strategies across the region.
EditorialAccess to medicines: From approval to
patient-centred deliveryThis issue focuses on access to medicines, and demonstrates how lifecycle regulation, diverse evidence, operational innovation and corss-sector collaboration all contribute to improving the timely, equitable and trusted delivery of medicines.
EditorialImproving outcomes with data
Every day, we make decisions based on learning, regulations and guidelines. We are surrounded by many forms of information and data is the fundamental unit. The data and the inferences and decisions we make from it depend on the quality we receive. High-quality data is essential for accurate and reliable ...