Knowledge Center

The CTIS is the pharmaceutical equivalent to EUDAMED. It will become the single entry point for clinical trial applications (CTAs) in the EU and the EEA countries (Iceland, Liechtenstein and Norway).  Its use will be mandatory for new clinical trials under the Clinical Trials Regulation after 31 January 2022.  There is a transition period of one year from the launch of the new Regulation where applicants can choose to file a clinical trial application under the existing Clinical Trials Directive or under the new Regulation.

 

The European Medicines Agency (EMA) has published a new handbook helping sponsors prepare themselves for using  CTIS, which is aimed at pharmaceutical companies, contract research organisations (CROs), small and medium-sized enterprises (SMEs), academic sponsors and any other organisations involved with clinical trials.

 

Some key points from the new Clinical Trial Regulation with respect to medical devices:

 

1. Patients do not have to pay for medical devices used for administering a pharmaceutical in a clinical trial unless the law of the Member State concerned states otherwise.
2. The cover letter which goes with the clinical trial application must include “a list of medical devices which are to be investigated in the clinical trial but which are not part of the investigational medicinal product or products, together with a statement as to whether the medical devices are CE-marked for the intended use.”
3. For “any sealed dosing device that contains the immediate package”, the following details must be stated on the immediate package:

(a)  name of the main contact; 

(b) pharmaceutical form, route of administration (may be excluded for oral solid dose forms), quantity of dosage units and, in the case of clinical trials which do not involve the blinding of the label, the name/ identifier and strength/potency; 

(c) batch and/or code number identifying the contents and packaging operation; L 158/72 EN Official Journal of the European Union 27.5.2014 

(d) a clinical trial reference code allowing identification of the trial, site, investigator and sponsor if not given elsewhere; 

(e) the subject identification number and/or the treatment number and, where relevant, the visit number; and 

(f) period of use (expiry date or re-test date as applicable), in month and year format and in a manner that avoids any ambiguity.

 

So if your medical device is involved in a pharmaceutical clinical trial, you need to be aware of the CTIS and the type of information you need to provide.

 

Our experts are fully aware that Clinical Trials are changing! You should be aware that the European Commission (EC) is scheduled to release the Clinical Trials Information System (CTIS) at the end of January 2022. It will be the single EU entry point and will be mandatory for new clinical trials. It is being introduced to reorganise and structure the manner and control of clinical trials in the EU and enhance patient safety, increase transparency and support innovation and research!

Companies may choose to file an application under the existing Directive or the Regulation during a one-year grace period following 31 January 2022. However, if your Clinical trial is launched before the implementation deadline, the Clinical Trials Directive is applicable through the end of January 2025.

 

The European Medicines Agency (EMA) has released training and supporting material on using CTIS to ensure compliance for those who will use it.

Our Experts are here to help and make sure that the information for your device being used in a pharmaceutical clinical trial is accurate and compliant with the requirements.

 

Please Connect with us for first free consultation 

Call Now: +353 (0)91-704804

Email us: mdd@mddltd.com

 

On 25th October 2023 

 

Clinical trials (CTs) authorised under the Clinical Trials Directive (CTD) likely to be ongoing beyond 30 January 2025 need to be transitioned to the Clinical Trials Regulation (CTR). Details of the requirements for transitioning CTs are provided in the European Commission’s Guidance for the transition of clinical trials.

The transition of clinical trials from the Clinical Trials Directive to the Clinical Trials Regulation (CTR) is open to sponsors until the end of the 3-year transitional period, on 30 January 2025, without the need to discontinue a clinical trial or put a trial on hold.

Sponsors should, however, take into account the time necessary for completion of the authorisation procedure under Chapter 2 of the CTR and the European Commission’s guidance. Therefore, sponsors are strongly advised to submit their applications prior to 30 January 2025 taking into account the assessment time, which can extend from 1 week (expedited process) to up to 106 days in case a full trial application is needed.

By late October 2023, only around 390 transitional trials have been submitted to CTIS out of an estimated 4,000 - 6,000 trials pending to be transitioned by 30 January 2025.
Further resources and guidance from the European Medicines Regulatory Network are available on the CTIS website (under the section “Transitioning Trials”) in order to support sponsors transitioning their trials to the CTR/CTIS.