H-1051 Budapest, Zrínyi u. 3.

Tel.: (1) 8869-300, E-mail: ogyei@ogyei.gov.hu

Mail: 1372 P.O. Box: 450.

MAGYAR

Adverse reaction reporting arising from clinical trials

SUSAR reports

OGYÉI still requires SUSAR reports originated from Hungary to organization ID „OGYI” via the EudraVigilance system. Indirect reporting is not applicable for clinical trial reports. Please send SUSAR reports in paralel to EudraVigilance central Clinical Trial Module (EVCTM), and to Organization ID „OGYI”.

Annual Safety Reports

DSUR reports (Development Safety Update Report) should be sent via client gate or in 1 CD to OGYÉI in 60 days after data lock point. Subject identification ID for DSUR submission is 3214. Please follow requirements detailed in guideline ICH E2F.

Urgent Safety Measures

Safety Notification Letters should be reported to OGYÉI immediately, within 24 hours. These kind of notifications should be reported to OGYÉI if a serious adverse reactions experienced has impact on the conduct of the study, or enhance risks of participation in the study (e.g. lack of efficacy in patients suffering from life threatening disease, new issue in non-clinical study, early termination or temporary halt of a study with the same IMP due to safety or lack off efficacy).

Documents intended to Central Ethics Committee should be sent directly to them. 

Contact in OGYÉI:

Dr. Éva Madarász

Tel.: +36 1 886 93 00/351

clinadr@ogyei.gov.hu

Q&A - Questions and answers regarding safety reporting in clinical trials

1.

General questions concerning safety concerns in clinical trials

1.1

The name of the Hungarian Competent Authority (OGYI) was changed to GYEMSZI, later to OGYÉI. Is still the receiver ID for reporting Hungarian SUSARs OGYI?

Yes, the receiver ID for reporting Hungarian SUSARs originated from clinical trials is OGYI.

1.2

Where should general questions regarding safety concerns be sent to?

The e-mails for general questions respecting safety concerns of clinical trials should be sent to clinadr@ogyei.gov.hu.

1.3

How should the Hungarian Competent Authority be informed about events affecting safety of the subjects or urgent safety arrangements?

Events affecting the safety of the subjects as well as urgent safety arrangements should be reported as Safety Notification Letters via client gate or by email clinadr@ogyei.gov.hu .

1.4

How should DSURs be submitted to the Hungarian Competent Authority?

DSURs should be reported via client gate or via courier ( OGYEI, Clinical Trials Department; H-1051 Budapest Zrinyi u. 3.) on CD in one copy.

1.5

Is the Hungarian Decree concerning the clinical trials (Decree 35/2005 (VIII. 26.) of the Minister of Health) available in English language?

No, it is not available in official English language and is not intended to have an official English translation.

2.

SUSAR reporting to the Hungarian Competent Authority

2.1

Should all SUSARs occured in a clinical trial approved in Hungary be reported to the Hungarian Competent Authority?

No, Hungarian Competent Authority should be reported about a SUSAR occured in a clinical trial approved in Hungary only if the event hits out in Hungary.

2.2

Is indirect reporting in EudraVigilance system is applicable for clinical trials?

Indirect reporting for SUSAR reporting purposes is not applicable until EU Regulation 536/2014 come into force. SUSARs occured in Hungary should be sent electronically to the EV Clinical Trial Module (ID: EVCTMPROD) and simultaneously to the Hungarian Authority’s Clinical Trial Module (ID: OGYI)

2.3

Does the Hungarian authority require testing and/or registration to be performed for EVWEB users/EV Gateway users for the electronic transmission of SUSARs?

No, the Hungarian authority does not require EVWEB users/EV Gateway users who are already in production with the EV Clinical Trial Module to perform additional tests or registration for the electronic transmission of SUSARs.

2.4

Does the Hungarian authority require sponsors to inform the Hungarian authority about introducing electronic transmission of SUSARs?

No, information of the Hungarian authority about the first electronic report being sent is not required. Acknowledgement of the first electronic SUSAR report proves that the system is working. A missing acknowledgement indicates a failure of the transmission and an e-mail should be sent to clinadr@ogyei.gov.hu.

2.5

Does the Hungarian authority require sponsors to submit paper copies of SUSARs?

No paper copies are required when sponsor is in full production.

2.6

Is there any data flow concerning SUSAR reports between OGYI and Ethics Commettee?

No, OGYI and Ethics Committee accept and evaluate the SUSAR reports separately. Submission to OGYI is carried out through EV system; submission to Ethics Committee is being conducted in electronic way (e-mail to safetyreport@emmi.gov.hu).

2.7

What should the sponsor do if an acknowledgement is not received in 48 hours?

If an acknowledgement is not received within 2 businessdays please contact clinadr@ogyei.gov.hu . Note: 2 businessdays do not automatically mean 48 hours. Please present the batch number of your SUSAR report in your e-mail.

2.8

Should the sponsor send individual SUSAR reports to the investigators?

No, in line with detailed guidance of European Commision (2011/C 172/01 Article 7.10, „CT-3”) and in line with Decree 35/2005 (VIII. 26.) of Minister of Health, Report of Serious Adverse Reactions, Article22(3) SUSARs do not have to be reported in an expedited way in the form of individual SUSAR reports to the investigators.

2.9

How should the sponsor inform the Hungarian authority about SUSARs in the case of a technical failure with EV system?

In the case of a technical failure with EV system, transitionally the sponsor needs to send the reports by email to clinadr@ogyei.gov.hu. Once the system is functional please send them electronically to OGYI CT Module.

3.

SUSAR Line Listing reporting

3.1

Could you confirm that a change has been carried out in the regulation of SUSAR Line Listing reporting in Hungary?

From 16 January 2014, SUSAR Line Listing should not be sent to the Hungarian Authority and Ethics Committee (including SUSAR Line Listings generated in clinical trials approved before 16 January 2014). SUSAR Line Listing must be sent only to investigators.

3.2

Is there a defined timeline on submitting national and international SUSARs in a Line Listings form to the investigators?

Contrary to the previous rules there is no a defined timeline on submitting SUSAR Line Listing to the investigators. In this respect Decree 35/2005 (VIII. 26.) of the Minister of Health, Report of Serious Adverse Reactions, Article22(3) follows the rules of 2011/C 172/01 Article 7.10.: periodicity of SUSAR Line Listing submission is defined by the nature of the research project/clinical development project and the volume of SUSARs generated.

3.3

Should the sponsor send SUSAR Line Listing reports to the investigators? Could you confirm whether this should be a listing of all SUSARs noted for the IMP for the reporting period, or just for the relevant study.

Information on SUSARs should be aggregated in a line listing form and forwarded to all involved investigators. This line listing including a brief report highlighting the main points of concern should contain all the information gained from the SUSARs originated from the whole clinical trial independently on the country where the event onset. The SUSAR line listing contains all SUSARs noted for the IMP for the reporting period.

3.4

How long is it obligatory to send SUSAR Line Listing to investigators? Shall it be stopped at the date of LPLV (last patient last visit) at a given site?

There are no rules that specify the time when supplying investigators with SUSAR Line Listing should be stopped. It is acceptable to stop sending Line Listing to Investigators after local last patient last visit was performed. However, it is strongly recommended to keep informed the investigators even months after LPLV because of safety concers of his/her patients (depends on the nature of the trial).

4.

DSUR (Development Safety Update Report) submission

4.1

Is it required to send DSURs with data gained from a clinical trial to investigators involved?

No, in line with 2011/C 172/01 Article 8., DSUR should only be submitted to the national competent authority and Ethics Committee.

4.2

On which format the annual safety report (DSUR) is to be submitted to you?

DSURs should be reported via client gate or courier (OGYEI, Clinical Trials Department; H-1051 Budapest Zrinyi u. 3.) on CD in one copy.

Central ethics committee receives DSURs in e-mail: safetyreport@emmi.gov.hu.

4.3

What is the frequency and deadline of submitting a DSUR?

A DSUR should be prepared after the first authorisation of a clinical trial worldwide (DIBD, Development International Birth Date). The first DSUR can be submitted to the Hungarian Authority earlier than 1 year, but the covered reporting period should not be longer than 1 year. The data lock point for a DSUR reporting period is the last day (or the last day of the month) before the anniversary of the DIBD.

4.4

After an end of trial notification should sponsor provide the Hungarian Competent Authority with DSUR?

Yes, Hungarian Authority requires to receive DSUR after end of trial notification, since annual safety reports must cover the full time period of an approved clinical trial. (Theoretically, months may last between the last DSUR submission of an ongoing study and end of trial notification). Besides, in this respect the Hungarian authority considers a clinical trial to be completed when a final study report is available (in line with glossary ICH E2F). This would mean a DSUR needs to be submitted to the Hungarian Competent Authority until the final study is completed.

4.5

If a clinical trial is suspended or not initiated in Hungary should the sponsor provide the Hungarian Competent Authority with DSURs?

If the Hungarian Competent Authority approved a clinical trial, DSURs must be submitted to the authority even in cases of not being any active site in Hungary.

4.6

When the same IMP is being developed by different sponsors, how DSUR submitting should be arranged?

As a general rule, when an IMP is developed by different sponsors, a single DSUR is preferred. Still, when the same IMP is being developed by different sponsors without a formal co-development agreement, it is acceptable if each sponsor submits his own DSUR. Similarly, in line with ICH guideline E2F section 2.4.2., when sponsors are in a formal co-development or licensing relationship, the parties should arrange to prepare a single DSUR, if possible. When a single DSUR cannot be arranged, multiple sponsors can agree to prepare separate DSURs for the same investigational drug.

 

Last updated: 2019.01.25 11:04