ECGeneralEthicalReview object

Submission for Ethical review mandatory for

All clinical investigations of MD

Submission to CA and EC to be performed in the following order

Only one single submission required

Procedural interaction between CA and EC during approval process

Yes

Procedural interaction - Additional information

Application for trial authorization, amendments and end of trial declaration should only be submitted to the HRTC (CA) in 2 identical copies.
HRTC sends a copy or relevant documents to TUKEB (EC).

Additional Information

The central ethics committees are officially appointed by law as public co-authorities (in the meaning of the general rules of public authority procedures). This is a specific Hungarian phenomenon.

The opinion of the co-authority (the ethical approval in the given case) is binding for the decision-making authority.

In the case of MD trials there can be two special authorities: ETT TUKEB, NIPN/OGYÉI (for combined products: MD+IMP).
Both sould be called upon excusively by the HRTC!

Regulatory and ethics bodies involved in approval process

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

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