European Medicines Agency updated the Clinical Trials Information System (CTIS) webinar: How sponsor organisations can prepare for CTIS event page on July 14, 2021, by adding a EU survey portal for participants interested in the webinar to submit questions in relation to sponsor preparedness in advance of the event, by July 20, 2021. Participants can submit up to 5 questions regarding a pre-specified agenda topic. It was also mentioned that the most popular questions submitted in advance will be answered by the speakers during the webinar.
Clinical Investigation of Medical Devices
According to an update posted on the Swedish Medical Products Agency (MPA), the national legislation with adaptations to EU regulation 2017/745 on medical devices (Medical Device Regulation) entered into force on 15 July 2021. The transitional requirements for clinical investigations of medical devices as per the new legislation are as follows:
- All applications and notifications for clinical investigation of medical devices in Sweden must be submitted to the MPA from 15 July 2021, until EUDAMED is fully functional. This also applies for those clinical investigations for which an ethics approval was previously sufficient
- Combined Submission Dossier: As of 15 July 2021, the ethics application is submitted by sponsor together with the application to the Swedish MPA in a combined submission dossier. The Swedish MPA will, upon receipt of an application or notification, forward relevant parts of the submission dossier to the Swedish Ethical Review Authority for assessment, so no separate submission to the Ethical Review Authority is required. With this new procedure, the sponsor is the applicant also to the Ethical Review Authority
- Clinical investigations initiated under previous legislation:
- Clinical investigations with ethics approval before 15 July 2021 may continue to be conducted in accordance with the provisions in MDR and need not submit an application or notification to the MPA retrospectively.
- For clinical investigations with ethics application submitted before 15 July 2021 but no ethical approval in place, sponsors are required to submit a copy of the ethics application and the decision letter from the Ethical Review Authority in the submission package to the Swedish MPA, after the ethical approval has been obtained.
For more details, please refer to Clinical Investigation of Medical Devices.
European Medicines Agency (EMA) published a document on the minutes of the management board meeting on the Clinical Trial Information System (CTIS) audit on July 14, 2021.
The meeting was held virtually on April 21, 2021. The main aim of this meeting was to confirm if the EU clinical trials Portal and Database (EUPD) are fully functional and meet the functional specification. EUPD is one of the deliverables and a key component of the Clinical Trials Information System (CTIS).
Publication of the European Commission (EC) notice confirming full functionality of the EUPD will start as soon as the Management Board letter of endorsement is received. The Commission will draft an act that is intended to be published on 31 July 2021, so that the Clinical Trials Regulation can start to apply 6 months later. Also, a Joint Action for clinical trials will be launched by the EC in 2021. Additionally, the EC declared that they would be providing the legal support required for the national implementation of Regulation (EU) No 536/2014.
The timelines of the CTIS application were reemphasized in the meeting. The system is set to go live by 31 January 2022 and in the first year after CTIS is live, the sponsor will have a choice to select the old or new system. From 31 January 2023, all the new applications will be submitted to the new system, and the old system will be available only for ongoing studies. From 31 January 2025, all the ongoing studies will need to move on to the new system and the EU Directive will no longer apply.
The document also provides a summary of EUPD independent audit methodology and findings, project release plan for go-live and post-go-live, CTIS training and communication programs and confirmation on EUPD functionality as per the Clinical Trial Regulation.
Detailed information on the above-mentioned points can be found here.
European Medicines Agency updated the Clinical Trials Information System (CTIS) webinar: How sponsor organisations can prepare for CTIS event page on July 12, 2021, by adding a live broadcast section for participants interested in the webinar. This broadcast section will be functional on the day of the webinar i.e., July 29, 2021.
To assist with further queries a point of contact has also been provided.
European Medicines Agency updated the page Clinical Trials Information System: training programme, on July 09, 2021, by adding new versions of the below documents in CTIS Training Module 17 (Supervise a clinical trial – Ad hoc assessment):
- Instructor’s Guide: Supervise a CT – Ad Hoc Assessment: It contains an overview of how to complete the ad hoc assessment form in CTIS including guidance steps, activities, exercises with solutions for trainers and screenshots for better understanding.
- Step-by-step guide: Supervise a CT – Ad Hoc Assessment: It provides step-by-step guidance on how to create, search and view an ad hoc assessment, with screenshots.
- FAQs: Supervise a CT – Ad Hoc Assessment: It contains questions regarding the creation, requests for information and consultation, the update and completion, the roles and permissions, the search, view, and download of an ad hoc assessment.
European Medicines Agency uploaded a PDF Speakers – Clinical Trials Information System (CTIS) webinar: How sponsor organisations can prepare for CTIS over the What’s New Section on July 08, 2021.
The document consists of bios of all the speakers that will be articulating in the upcoming CTIS webinar-Clinical Trials Information System (CTIS) webinar: How sponsor organisations can prepare for CTIS that will be held on July 29, 2021.
Additionally, the agenda for the event was uploaded on July 06, 2021, on the event page.
European Medicines Agency updated the page Clinical Trials Information System: training programme, on July 06, 2021, by adding new versions of the below documents in CTIS Training Module 15 (Search, view and download a clinical trial and clinical trial application):
- Instructor’s Guide: How to search, view and download a CT and a CTA (Authority): It is a guidance document for authority users and contains an overview of the training materials available, and a suggested methodology for disseminating the materials. It also explains different case by case scenarios with possible solutions, justifications and screenshots for better understanding.
- FAQs: How to search, view and download a CT and a CTA (Authority): It includes questions related to searching, viewing, and downloading CT and/or CTA.
- Quick guide:How to search, view and download a CT and a CTA (Authority): It includes steps for searching, viewing, and downloading CT and/or CTA along with detailed screenshots and explanation for each section of CTA.
- Step-by-step guide: How to search, view and download a CT and a CTA (Authority): It includes steps in brief with screenshots for searching, viewing, and downloading CT and/or CTA along.
European Medicines Agency updated the page Clinical Trials Information System: training programme, on June 30, 2021, by adding new versions of the below documents in CTIS Training Module 07 (Management of registered users and role matrix):
European Medicines Agency updated the page Medical devices, on June 29, 2021, by adding a questionnaire with respect to the implementation of the Medical Devices and In Vitro Diagnostic Medical Devices Regulations ((EU) 2017/745 and (EU) 2017/746).
The PDF document has been uploaded to provide explicit guidance to Applicants, Marketing Authorisations Holders (MAH) and notified bodies (NB). The question and answers in this document are mainly related to regulatory framework and submissions of medical devices under the new Regulation (EU) 2017/745, and Regulation (EU) 2017/746. It covers questions in relation to medical devices that form an integral product with a medicinal product, medicinal products that include a medical device in the secondary packaging of the marketed medicinal product (co-packaged), and consultation procedure for ancillary medicinal substances that are integral part of medical devices.
This document will be updated regularly and will be marked by “New” or “Rev.” with the relevant date upon publication. As of now, the document does not contain any questions regarding transparency.