TranspariMed published an article How will national regulators in Europe impose fines for missing clinical trial results?
In this article, TranspariMED’s legal analyst Muhammad Dwistaraifa Rasendriya explains the legal context and how the process will work. As a summary, even though national medicines regulators will get clear legal powers to impose fines and other sanctions on European companies and institutions that fail to make the results of their drug trials public, there will be variation in the amount/type/applicability of the penalty depending on what act/law is passed in each EU country.
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Day 2 of the SME and academia Clinical Trials Information System (CTIS) two-part training webinar arranged by EMA took place on March 04, 2021. EMA has made available the presentations from Day 2 of this CTIS training webinar on March 03, 2021.
SME and academia Clinical Trials Information System (CTIS) two-part training webinar were announced on 19/01/2020. This two days training webinar would provide essential information on CTIS for micro, small and medium-sized enterprises (SMEs) and non-commercial (academic) sponsors.
Day 1 of the webinar would be held on 22 February 2021. It will cover:
- Overview of CTIS
- User access management, including how to register users
- Sponsor user management
- Sponsor roles and permissions in CTIS
Day 2 of the webinar would be held on 4 March 2021. It will cover:
- Submitting an initial trial application in CTIS
- Updating an initial trial application, including making substantial modifications and adding a Member State concerned
- Making non-substantial modifications
- Submitting trial results
Registration must be done by completing the expression of interest questions by 29 January 2021. Registrations will close on 7 February 2021. Registration for each day of the webinar must be done separately. The webinar is limited to 950 participants only. EMA will publish the video recording of the webinar.
IT systems temporarily unavailable from 31 December 2020 to 1 January 2021
Several European Medicines Agency (EMA) information technology (IT) systems will be temporarily unavailable between 08:00 on Thursday 31 December 2020 and 18:00 on Friday 1 January 2021 (Central European Time, CET).
This is due to essential maintenance related to the end of the transition period for Brexit: the United Kingdom’s withdrawal from the European Union. EudraCT, EMA Account Management, Clinical data website are among the systems to get affected due to this maintenance next week.
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EMA Management Board: highlights of December 2020 meeting were published on 18/12/2020. The section Update on the EU IT systems required by the Clinical Trial Regulation summarizes the progress with respect to CTIS.
Additionally, the EMA page for CTIS updates has been updated to include below post, which covers the key points from EMA management board meeting highlights:
In 2021, EMA plans to focus on:
- the findings of a system audit;
- improving usability, quality and stability of the CTIS;
- knowledge transfer to prepare users and their organisations for CTIS.
It is also working towards go-live in line with a plan developed together with the Member States and to deliver a minimum viable product (MVP). The CTIS programme governance is responsible for agreeing what the MVP will consist of.
Go live is planned in December 2021.
The second issue of the Clinical Trials Information System (CTIS) Highlights is published on December 09, 2020.
This issue explains the CTIS benefits, CTIS features including user administrators and roles, member states and sponsor interaction, CTIS training and audit.
Additionally, it also provides the future developments for CTIS as below:
Go-Live is planned for December 2021 and CTIS will be further
developed to include:
- The safety reporting module which will be fully combined with
the CTIS components and other safety reporting features will
- The sponsor workspace with enhanced functionalities;
- Enhanced functionalities available for oversight, cooperation,
supervision and visibility within and among Member States;
- Improved users’ navigation and experience.
After Go-Live more functionalities will be released such as:
- The public register will be enhanced;
- Reporting, cooperation, interoperability functionalities will be
- User experience features will be further strengthened.
The below update is posted on EudraCT What’s New section, on December 07, 2020. The information is not new as such, and all the points that have been published so far regarding the Brexit and the action required therefore, are reported in a summary format. The sponsor is required to make changes to the Clinical Trial Application (CTA) as mentioned below:
From January 1st, 2021, for all clinical trials recorded in EudraCT that are ongoing in the EU/EEA:
- Sponsors established in the United Kingdom prior to 31 Dec 2020, must as of 1 January 2021 be legally established in the EU/EEA or have a Legal representative who is legally established in the EU/EEA.
- Legal representatives established in the United Kingdom prior to 31 December 2020 can no longer act as a legal representative of a UK sponsor as of 1 January 2021.
- Qualified persons established in the United Kingdom other than in Northern Ireland can no longer certify batch-release of an IMP for use in EU/EEA as of 1 January 2021 and must be established either in the EU/EEA or in Northern Ireland.
Sponsors are requested to update these requirements in sections B.1, B.2 and/or D.9.2 of the Clinical Trial Application (CTA) form, as appropriate, using the EudraCT application (click on “EudraCT number, CTA & Login for posting results”, then “load -> EEA CTA”, add the CTA XML file, perform the changes and save the CTA file locally). The amended XML file of the CTA will then need to be submitted to all the relevant National Competent Authorities where the trial is submitted/ongoing.
Please note that it is already possible for sponsors to modify the XML file of their CTAs with the following:
- Update section B.1 with a sponsor based in EU/EEA
- Update section B.2 with a EU/EEA legal representative for third country sponsors having a legal representative based in UK
- Update section D.9 with a Qualified Person based in EU/EEA
In addition, from January 1st, 2021 sponsors will be able to perform the following changes in the CTA:
- Update section B.2 with a EU/EEA legal representative, for trials with sponsors based in UK
- Update section D.18.104.22.168 specifying “Northern Ireland” in the country field
When submitting the updated XML file of the CTA to the National Competent Authority, the sponsor is requested to make a reference to the relevant substantial amendment form already submitted.
EudraCT posted the following update on November 24, 2020:
The Frequently Asked Questions document has been completely revised. Sponsors are encouraged to refer to it for questions on EudraCT/EU CTR. Comments and suggestions on the document are also welcome, to be sent via the Service Desk.
The Service Level Agreement for the addition of a new active substance in EudraCT has changed. Now it could take 5-10 days to have a substance added in section D. of the Clinical Trial Application form. The process is described in the Frequently Asked Questions.