EMA workshop on development pathways for Advanced Therapy Medicinal Products

The EMA has published a report on its workshop “Development Pathways for Advanced
Therapy Medicinal Products”, which took place in London on December 15, 2014.  The meeting was the 3rd in a series of annual workshops, with more than 130 participants from a broad range of public and private stakeholders in attendance.

Workshop participants engaged in discussions on the adequacy of business development models for such products, the implementation of the ATMP legislative framework and the legal and regulatory provisions available, such as the ATMP certification scheme, guidance on the risk-based approach and hospital exemptions. Other topics raised included the recent regulatory initiatives to support early access e.g. parallel EMA scientific Advice with Health Technology Assessment bodies (HTAs) (link) and adaptive pathways.