CATrialAuthorisation object

Regulatory and ethics bodies involved in approval process

Competent Authority/-ies (CA)
Ethics committee(s)
Other

CA - Submission for authorisation mandatory for

Interventional IMP trials

CA - Submission required to

National CA
Other

Specific Competent Authority for ATMP trials in place

Yes

Competent Authority for ATMP trials

Swedish Gene Technology Authorities
(the Authorities responsible for the regulations of activities involving GMOs)

In addition to MPA approval, a notification or application for permit might be necessary to be submitted to the Swedish Work Environment Authority SWEA (LVFS 2004:10). The rules are specified in SWEA Provisions (AFS 2011:2) on contained use of genetically modified micro-organisms.

Additional Information

Non-interventional studies (e.g. Epidemiological studies following AE on the market) will only be assessed by EC, not CA. Interventional studies will be judged by both CA and EC

If ionising radiation is used the following authority shall be additionally involved:
Swedish Radiation Safety Authority

This project (ECRIN Integrating Activity/ECRIN-IA) has received funding from the European Union’s Seventh Framework Programme for research, technological development and demonstration under grant agreement no 284395