Academic GMP facilities play a pivotal role in the development of advanced therapy medicinal products (ATMPs). Until now, only a few ATMPs have received marketing authorization but many (new) ATMPs are currently tested in clinical trials or are administered to patients under the hospital exemption (HE) clause of the ATMP-regulation.
On the 12th of June, we launched a survey to get more detailed information on the impact of the current ATMP-regulation. We set up this survey to:
1) collect information of the regulatory framework within each European Country
2) strengthen the position of academic centers by asking your opinion of how the Regulation might be altered.
In this 10 minute survey we ask participants about their experience with getting approval for the products either in clinical trials or under the hospital exemption. The information will be evaluated and shared with the network and regulators in Europe.