Europe – Pandemic highlighted challenges of ATMP clinical trials in Europe

A conflict between European regulations governing clinical trials and those governing the use of genetically modified organisms (GMO) was distinctly exposed by the COVID-19 pandemic, Charlie Mortazavi said here at RAPS Euro Convergence.

That attention and future clarification of the regulations could help clear the way for clinical trials of advanced therapy medicinal products (ATMP) in Europe, said Mortazavi, senior manager of global regulatory affairs at Sanofi in Paris.

During the COVID public health emergency, the European Commission waived compliance with the GMO directives for vaccines and therapeutics to address the pandemic. As a result, vaccines and treatments were able to come to market very quickly.

“This was motivated only by the health crisis and when it is over, sponsors will need to comply with the GMO directive again,” Mortazavi said.

He pointed out that between 2014 and 2018, new clinical trials for ATMPs started in the US increased by 36%, while Asia saw a 28% increase. During the same period, trials started in Europe increased by less than 2%.

While the reasons behind this stark difference are multifold, the European GMO legal framework plays a part, he added…