OGEYI, Hungary, posted an update regarding the procedure for authorization of new clinical trials under Regulation 536/2014 on February 24, 2022.
According to the update, the application must be submitted through the CTIS system and all communication will take place on the CTIS interface. Sponsors can either submit Part I and Part II documents together or can choose to submit Part II within two years of authorisation.
The Member States will carry out formal checks, and if the designated Member State does not assume the role of reporting Member State (RMS), then an RMS would be selected. The RMS would then notify the principal and the other member states that it is acting as a reporting Member State. On the 10th day, the RMS will notify the principal of any deficiencies in the documentation. Sponsors should provide the missing documents within 10 days. Member states will assess the new documents within 5 days and the RMS would then notify the principal about the fate of the application, latest by the 25th day.
In cases where Part II documentation is submitted later, OGEYI will carry out the formal check and notify the client of any deficiencies in documentation within 10 days. If required, the applicant must submit the missing documents within 10 days. The OGYÉI will notify the client of the fate of the application within 5 days of receiving the missing documents.
Evaluation
The RMS will forward Part I of the evaluation report (RFI Part I) to the principal and the other Member States concerned within 45 days of validation, along with its conclusions. If required, the client must answer the questions and also submit the requested documentation. (Response to RFI).
For part II documents, the ethics committee (ETT-KFEB) will prepare Part II of the evaluation report within 45 days of validation and the OGYÉI will notify the client of the comments. (Part II RFI). In the case of complete documentation, the OGYÉI shall make the Part II RFI available at the same time as Part I of the evaluation report. If required, the client must answer the questions within 12 days and also submit the requested documentation.
If a reply is not received by the deadline for both Part I and II requests, the CTIS will be closed and the authorisation procedure will be terminated.
Member States have 19 days to assess the information received. On the 76th day, the reporting Member State will finalise the Part I and/or Part II evaluation report taking into account the additional information and will notify the principal of the outcome of the evaluation. (Final Conclusion).
