Stakeholder workshop on support to quality development in early access approaches, such as PRIME and Breakthrough Therapies

The aim of this workshop was to discuss scientific and regulatory approaches which could be used to facilitate development and preparation of robust quality data packages, to enable timely access to medicines for patients whilst assuring that patient safety and product quality are not compromised. 

Participants looked at specific industry case studies covering chemicals, biologicals and advanced therapies and experiences across different regions. 

EMA and the United States Food and Drug Administration (FDA) launched PRIME and Breakthrough Therapy schemes to strengthen their support to the development of medicines for unmet medical needs to help patients to benefit from these therapies as early as possible. This workshop is a joint collaboration between EMA and the FDA.

EMA has published a report on the workshop, containing recommendations from participants on next steps and areas to be further explored by EMA and the FDA.