Europe – Pharma group decries EU’s ‘fragmented’ system for GMO-containing medicines

The European Federation of Pharmaceutical Industries and Associations (EFPIA) is calling for greater harmonization of genetically modified organism (GMO) procedures for investigational medicinal products, saying the complex process has the potential to slow the initiation of clinical trials for advanced and cellular therapies.

In a perspective article in Cell & Gene Therapy Insights and a related press release, EFPIA said the current system is more restrictive than GMO requirements in the US and runs the risk that Europe will be perceived as being “less attractive to sponsors.” Since 2015 the United States has had a categorical exclusion for investigational advanced therapeutics and vaccines, the group said…