EMA and the US Food and Drug Administration (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.
The aim of the workshop is 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.
The event, which is a joint collaboration between EMA and the US Food and Drug Administration (FDA), intends to explore opportunities and best practices between the agencies and industry to further facilitate the successful development and authorisation of priority medicines.
This workshop will also bring together experts from EMA's Biologics Working Party, Quality Working Party and Inspectors Working Group, international partners and industry representatives. Participants have been invited to submit case studies related to key manufacturing challenges (e.g. control strategy, stability) prior to the meeting. Some of these will be discussed during the event to explore scientific and regulatory approaches that could be used to overcome those challenges.
EMA will publish a report on the workshop on its website. Additionally, the Agency will consider the opportunity to develop recommendations and further guidance for applicants based on the experience gained so far and the feedback received during the event.
The workshop will be held from 9:00 to 17:30 UK time at the EMA premises in London. It will be broadcast live and can be followed by clicking on the 'multimedia' tab on the event page. An Agenda - Stakeholder workshop on support to quality development in early access approaches, such as PRIME and Breakthrough Therapies is available.