Europe – Trade Group Calls for EU to Cut Review Times for ATMP Clinical Trial Filings

The Alliance for Regenerative Medicine (ARM) has called for Europe to streamline approval of clinical trials of advanced therapy medicinal products (ATMP). ARM wants regulatory agencies to cut review timelines and harmonize their approaches to support development of cell and gene therapies.

Europe has played a central role in the emergence of ATMPs. The European Medicines Agency (EMA) approved a gene therapy long before its regulatory peers and was the first authority to adopt specific rules covering the development and approval of the nascent class of medicines. However, a survey of ATMP developers run by ARM suggests the European Union may be losing ground as a destination for clinical trials.

The survey found clinical development activity in Europe is flatlining, with sponsors starting 2% more trials in 2018 than in 2014. In contrast, the number of clinical trials initiated in North America and Asia rose by 36% and 28%, respectively, over the same period…