EMA launches form for not-for-profit development programmes and hosts workshop on regulatory sandboxes

Two recent developments from the European Medicines Agency (EMA) demonstrate a focus on regulatory engagement around not-for-profit development programmes and regulatory sandboxes.

First, EMA has opened a voluntary form through which academic institutions and not-for-profit organisations can share information about medicinal products and therapies they are developing. Designed as an ongoing data collection tool, the form will help EMA anticipate regulatory submissions and tailor its support accordingly.

Organisations that opt in may be contacted by the EMA Academia office for early engagement. Eligible not-for-profit developers may also benefit from fee incentives for Scientific Advice.

Secondly, on 21 September, EMA and the European Commission held a joint workshop on regulatory sandboxes as laid out in the new pharmaceutical legislation. Regulatory sandboxes are a tool intended to facilitate innovation by providing an experimental environment in which innovative products, or categories of products, that encounter roadblocks under existing regulatory frameworks can be explored in a structured, time-limited manner. 

Regulatory sandboxes are among the first provisions of the revised pharmaceutical legislation to move towards implementation. The workshop brought together speakers from EMA, the European Commission and the IHI BRIDGE Consortium and representatives from national competent authorities, industry, and patient and healthcare organisations, to examine how sandboxes could work in practice and raise important considerations for their development and execution.

A key message from the workshop was the importance of engaging regulators early on innovative products, technologies or methodologies to explore whether a regulatory sandbox may be appropriate and, if so, how it could be designed. Developers, including SMEs, start-ups, non-profits and academic researchers, were encouraged to approach EMA early, including through its Innovation Task Force. 

The event recording, presentations and related documents are available here. PAREA is engaging with the EMA and closely monitoring developments around regulatory sandboxes and other initiatives relevant to innovative mental health interventions that do not fit neatly within established regulatory pathways, including psychedelic therapies.