EMA: Regulatory Guidance Hinders Development of ATMPs

February 9, 2017

Advanced therapy medical products are facing several development hurdles, ranging from inadequate regulatory guidance to insufficient funding, the EMA said.

Almost a decade after regulations to speed ATMP approvals first took effect; critical issues continue to hinder the development of the therapies, which are based on genes, cells, and tissues.

In a conference summary published Friday, the EMA offers examples of challenges sponsors face when developing and manufacturing ex vivo autologous and gene therapy products. It also identifies some problems related to centralized manufacturing.

View today's stories