Posted by Michael Wonder on 31 Jul 2019
Supporting medicine developers in generating quality data packages in early access approaches (PRIME and breakthrough therapies)
31 July 2019 - EMA and the US FDA have published today a report on their joint workshop with stakeholders held on 26 November 2018.
The aim of this workshop was to discuss scientific and regulatory approaches to address quality and manufacturing challenges encountered during the development of medicines under early access programmes, such as the PRIority MEdicines scheme (PRIME) in the European Union and the Breakthrough Therapy designation in the United States.
The report contains recommendations from participants on next steps and areas to be further explored by EMA and the FDA.
