Category: Belgium

European Medicines Agency updated the EudraCT homepage by providing the following update over the What’s New section on November 14, 2022:

There are issues reported by the users with uploading clinical trial application (CTA) XML files on EudraCT. This issue is caused by a SPOR malfunction impacting EudraCT and CTIS.

As of November 21, 2022, this issue is now resolved by EudraCT IT.

European Medicines Agency updated the event page Clinical Trials Information System (CTIS) bitesize talk: Notifications – Part 1 over the What’s New Section on October 26, 2022:

The video recording of the CTIS bitesize talk held on September 28, 2022, is now available on the event page. This bitesize talk provided an opportunity for sponsors to learn about the notifications related to trial and recruitment period, e.g. start, end, restart and halt of trial etc.

Also, new version for the below documents were added in Module 08 – Evaluate a clinical trial application: Assessment and decision-making by adding information on uploading the ‘not for publication’ documents in CTIS:

1. Quick guide – Part I : How to evaluate a clinical trial application: assessment and decision (v1.4)
2. Quick guide – Part II : How to evaluate a clinical trial application: assessment and decision (v1.4)

The eleventh issue of the Clinical Trials Highlights was published on October 21, 2022. Below are the key updates:

• Over 100 clinical trials have now been authorized by the Clinical Trials Information System (CTIS)
• Updated guidance on the protection of personal data and commercially confidential information (CCI) in CTIS will be provided in future issues considering the feedback received during the workshop and the 5-month public consultation period that concluded on 8 September 2022.
• The CTIS Forum including CTIS users and experts from Member States, EU sponsors (Academia, Industry), Clinical Research Organisations (CROs), patients, and from healthcare professionals will meet quarterly to discuss the CTIS functionalities, system use, and development, as well as user support and knowledge acquisition.
• EMA is currently reviewing all the responses received during Survey 3.0 for CTIS Sandbox and will provide eligible participants with access to CTIS Training Environment by the end of October 2022. The web address to CTIS Training Environment has also changed and users have been provided with the new web address through the e-mail account.
• After October 18, 2022, administrators will have to indicate both the user ID and the email address of the user to assign roles to users in their organizations in CTIS.

To know more about the upcoming CTIS events like CTIS walk-in clinics, organization management service (OMS) troubleshooting sessions, CTIS Webinar – 9 months on and going forward, bitesize talks and sponsor end-user training programs that will be held in November and December 2022, please click here.

European Medicines Agency updated the event page Clinical Trials Information System (CTIS): Walk-in clinic over the What’s New Section on October 12, 2022:

The video recording of the CTIS walk-in clinic held on September 20, 2022, is now available on the event page. Walk-in clinics provide a platform for sponsors to receive practical advice on the CTIS system functionalities by asking questions to CTIS experts.

European Medicines Agency updated the page Clinical Trials Information System (CTIS): online modular training program on October 05, 2022. A new version of FAQs: How to evaluate a CT application (v1.4) was added in Module 06- Evaluate a clinical trial application: Selection of reporting Member State (RMS) and validation of the clinical trial application:

The questions and answers that are added in this version are –

1. Section 4.9: This section provides information on uploading ‘documents not for publication’ with screenshots for better understanding.
2. Section 4.10: This section provides information on raising a consideration for an application section or document that is not included in the ‘Application section and document’ drop-down list.

As communicated by CT.Communication (a part of European Medicines Agency) below are the updates on the reactivation of the CTIS public portal:

• The CTIS public portal search function has now been reactivated, allowing users to search and access published clinical trials data.
• As a temporary measure, the clinical trials with any type of deferrals with a decision issued after mid-August and new clinical trial applications will not be published on the CTIS public portal for now. These clinical trials will be published on the CTIS portal once the full functionality of the deferral mechanism is restored and this date will be communicated in due course.
• Additional information was provided on the issue of “premature publication of information related to a limited set of clinical trials on the public portal” for which investigation and resolution were ongoing which resulted in the unavailability of the CTIS search function on the public portal.

The article “EU Seeing Success in Trial Transparency, but Some Nations Holding BackStrong progress on trial reporting in Europe – but some players still lag behind” has been published on October 03, 2022, on Center Watch.

As per the analysis conducted by TranspariMED, Health Action International, and Transparency International Global Health, there has been an 83.6 percent increase as of July 2022, in results posting for the due clinical trials since European Medicines Agency started reaching out to the sponsors.

Additionally, individual EU countries like Austria, Belgium, Denmark, Finland, Germany, and the Netherlands are actively pushing sponsors and investigators to publicly share the results of past trials, now by passing legislation to impose the below fines upon failure to report results:

1. Belgium: €500 to €250,000
2. Austria: €25,000 to €50,000
3. Germany: maximum €25,000
4. The Netherlands’: maximum €33,500

Some countries’ fines may be multiplied by applicable surcharges and even carry jail time, while others appear to be single charges. Denmark, Sweden, and Finland have not decided on the fine amount yet.

In the future, European regulatory agencies plan to use data monitoring from CTIS to catch violations. Austria, Belgium, Finland, and Germany plan to use these data alongside GCP inspections, while Denmark will supplement these data with national monitoring efforts.

There are no updates in countries like Italy, France, and Spain regarding action on the missing drug trial results.

European Medicines Agency updated the event page, Clinical Trials Information System (CTIS) bitesize talk: Notifications – Part 1 over the What’s New Section on October 03, 2022:

The presentation for the CTIS bitesize talk held on September 28, 2022, is now available on the event page. It briefly explains the trial and recruitment period notifications as per the sponsor activities during the life-cycle of a clinical trial. It also provides information on the notifications for the end of the trial, temporary halt, and restart of a clinical trial.

European Union Drug Regulating Authorities Clinical Trials Database (EudraCT) posted an update on the What’s New section on September 26, 2022:

The EMA Service Desk has changed to ServiceNow and can be accessed via https://support.ema.europa.eu/esc. If the service desk is not accessible through the provided link, users can report their issues or ask questions at the email address – [email protected].