sesp5 - Trends Supporting Access to Medicines for Patients

Key ICH guidelines harmonizing advanced manufacturing approaches such as ICH Q12 and ICH Q13, along with greater international collaboration and other trends supporting more efficient access to medicines for patients, will continue to evolve. The COVID-19 pandemic allowed regulatory authorities to test some innovative tools while also demonstrating a great need for enhanced global collaboration among regulators. Challenges across the supply chain, leading to shortages, and other pressures such as the need for increased access to personalized medicines made at the point of care, require increased agilities and innovation in manufacturing. Other trends with increased focus on underserved populations to support greater inclusion of diverse patient populations during product development and in the post-market add to the complexity of the life-cycle management of products. Improved efficiencies in product development, clinical trials, manufacturing, and post-market surveillance, including leveraging data systems, AI, and real world evidence for product management, will be required to launch global product development and regulation to the next level.