Posted by Michael Wonder on 21 Nov 2018
Workshop on how to better support medicine developers in the generation and preparation of quality data packages for PRIME and Breakthrough Therapy application
20 November 2018 - EMA and the US FDA are organising a workshop on 26 November 2018 to discuss how regulators can better guide and support medicine developers in generating quality and manufacturing data packages in the context of development support programmes, such as the PRIority MEdicines scheme (PRIME) in the EU and Breakthrough Therapy designation programme in the US.
The goal is to help patients to benefit as early as possible from these therapies that target serious or life-threatening diseases or unmet medical needs.
Since the launch of EMA’s PRIME scheme in 2016, and FDA’s Breakthrough Therapy designation programme in 2012, both programmes have succeeded in driving innovation and encouraging drug development in therapeutic areas with the most pressing serious or life-threatening diseases and unmet medical needs. However, experience gained with these programmes has shown that applicants who are part of the scheme often face challenges in meeting the data requirements on quality and manufacturing development.
