Changes in the reporting of adverse events from clinical trials - in connection with the EU Regulation 536/2014
SUSAR reports
From the 31st of January 2022, SUSARs that occurred in Hungary will only be reported to the Clinical Trial Module (EVCTM) of the EudraVigilance system. Parallel (direct) reporting to the “OGYI” organization ID will no longer be required. All SUSARs - regardless of the authorization procedure (i.e. under Directive 2001/20/EC or EU Regulation 536/2014) - should only be reported to the EVCTM, even if no trial is running with that active substance under the Regulation yet.
Annual Safety Reports
If at least one study with a given active substance is already running under the Regulation, annual safety reports should be submitted to the CTIS (Clinical Trials Information System).
Before registering at least one clinical trial with the given active substance in the CTIS, the former submitting methods should be used (client gate – official customer portal provided by the Hungarian government; CESP, transfer, Eudralink).
We do not require paper copies or CDs. Submission by email is not considered official.
Urgent Safety Measures
Urgent Safety Measures (or other types of significant safety notifications) should be submitted to the CTIS if the clinical trial affected by this safety information is authorized under the Regulation.
If the safety notification relates to a study running under the Directive, the former submission procedures (client gate – official customer portal provided by the Hungarian government; CESP, transfer, Eudralink) should be followed. The same applies if there are already clinical trials with an active substance under the Regulation, but the given safety notification is not related to those studies.
If the safety notification relates to more studies, including some authorized under the Regulation and others under the Directive, the documentation should be submitted according to both methods in parallel.
For requirements of the Central Ethics Committee (ETT KFEB), please browse their website or contact the Secretariate directly: kfebtitkarsag@emmi.gov.hu.
Contact person from OGYÉI:
Dr. Madarász Éva
Tel.: +36 1886 93 00/351
Q&A - Questions and answers about safety reports from clinical trials
– to be updated later
