1051 Budapest, Zrínyi utca 3.

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

1372 Postafiók 450.

ENGLISH

Változások a klinikai vizsgálatok során tapasztalt nemkívánatos események jelentésével kapcsolatban

SUSAR jelentések

A Magyarországon jelentett SUSAR eseteket továbbra is az EudraVigilance rendszeren keresztül az „OGYI” organisation ID-n fogadjuk. Indirekt jelentésre  jelenleg még (az 536/2014 EU regulációt kiszolgáló EU-s informatikai fejlesztés megvalósításáig) nincs lehetőség. Kérjük, hogy a SUSAR reportokat továbbra is párhuzamosan küldjék be a centrális EudraVigilance klinikai modulba (EVCTM), és az Intézetnek az OGYI organisation ID-ra.

Éves Gyógyszerbiztonsági jelentések

A DSUR (Development Safety Update Report) jelentéseket kérjük, hogy cégkapun keresztül, vagy 1 CD példányon (cégkapuval nem rendelkező/külföldi benyújtó) küldjék be Intézetünknek a 3214 ügycsoport azonosítóra az adatlezárást követő 60 napon belül. A DSUR-ok összeállításakor az ICH E2F guideline szempontjait kérjük követni.

Urgent Safety Measures

Sürgős biztonságossági intézkedést igénylő új információról (Safety Notification Letter) haladéktalanul, de legkésőbb 24 órán belül értesíteni kell írásban az OGYÉI-t. Abban az esetben kell ilyet kiküldeni, ha a súlyos mellékhatás jelentékeny mértékben érinti a vizsgálat lebonyolítását, vagy növeli a vizsgálati alanyokra irányuló kockázatot (pl. kezelés elmaradása esetén életet veszélyeztető betegségben szenvedő populáció vizsgálatában hatástalanság igazolása, állatkísérletes vizsgálatokból származó új, jelentős biztonságossági információ, a szponzor azonos vizsgálati gyógyszerével folyó más vizsgálat idő előtti leállítása, vagy felfüggesztése biztonságossági okból.)

 

A ETT-KFEB-nek szánt dokumentumokat kérjük közvetlenül az ETT-KFEB-nek küldeni.

 

OGYÉI kontakt:

Dr. Madarász Éva

Tel.: +36 1 886 93 00/351

clinadr@ogyei.gov.hu 

Q&A - Kérdések és válaszok klinikai vizsgálatok biztonságossági jelentéseivel kapcsolatban

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 regarding 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 to clinadr@ogyei.gov.hu 

1.4

How should DSURs be submitted to the Hungarian Competent Authority?

DSURs should be reported via client gate (for Hungarian clients who have client gate), or  via courier as before, for clients submitting from abroad. (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 requires SUSARs occurred 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 comes into force. SUSARs occurred 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, informing 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 Committee?

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 message 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?

Relating to SUSAR submission, there is no 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 of 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 specifying the time when providing 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 about 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

In which format the annual safety report is to be submitted to the Hungarian National Competent Authority?

From 2011 annual safety reports should be sent in DSUR format, which is the ICH E2F format.

DSURs should be sent 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 yearly 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 from the Hungarian authorization, 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 an „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 the „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 the glossary of ICH E2F). This would mean a DSUR needs to be submitted to the Hungarian Competent Authority until the final report is completed/published.

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 if there were not 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  that 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.

 

Frissítve: 2019.01.25 11:08