Pharmacopoeial convergence and harmonisation are critical tools to promote the alignment of quality standards to ensure consistent global access to quality medicines for the benefit of public health. The United States Pharmacopeia (USP) and the European Pharmacopoeia (Ph. Eur.) are committed to working together to pursue effective and efficient avenues for convergence and alignment of quality public standards. Prospective harmonisation provides an opportunity for USP and the Ph. Eur. to align on standards for selected active substances and medicinal products that do not yet have public standards in either pharmacopoeia. This work focuses on medicines that are still under patent (single source), have newly approved applications, and have a strong impact on global public health.
USP and the Ph. Eur. began this project in 2008 as a pilot which resulted in the development of four prospectively harmonised monographs for active substances (Celecoxib, Montelukast sodium, Rizatriptan benzoate, Sildenafil citrate). Following completion of the pilot, USP and the Ph. Eur. continued work through an informal mechanism of information sharing that has resulted in the inclusion of 10 and 9 additional prospectively harmonised active substances and medicinal product monographs, respectively.
This webinar explores the history of the prospective harmonisation activities between USP and the Ph. Eur., highlight success stories as well as challenges, and share proposed program adjustments based on lessons learned. It also includes an overview of the respective processes for monograph development and presents the benefits and advantages of working with USP and the Ph. Eur. for future development of prospectively aligned active substance and medicinal product monographs.
Duration: 30 minutes
This webinar is of interest to professionals working in pharmaceutical companies in quality control, development, manufacturing, and regulatory affairs.