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01. March 2023 : Tips for Clinical Trial Sponsors: Regulation (EU) No 536/201420

01. March 2023 : Tips for Clinical Trial Sponsors: Regulation (EU) No 536/2014

A quick guide on the rules and procedures of the updated Clinical Trials Regulation (CTR) EU No 536/2014 was just released. This guidance, drawn up by the Clinical Trials Coordination and Advisory Group (CTAG), is meant as a practical approach for clinical trial (CT) sponsors and investigators to help implement the new rules. 

Even though we are still on a transition period until the 31st of January 2025 for full CTR application, by then all sponsors who wish to conduct clinical trials for a medicinal product (national and multinational) in the European Union (EU) / European Economic Area (EEA) will have to comply to the updated CTR.

First, sponsors should carefully assess the relevance and feasibility of the planned CT. The protocol and dossier should be prepared in advance; an insurance/compensation should be in place; and the safety surveillance and capability for Suspected Unexpected Serious Adverse Reactions (SUSAR) reporting to EudraVigilance should be organised before the submission takes place.

To access the Clinical Trial Information System (CTIS) sponsor-workspace, a user will need to self-register for a European Medicines Agency (EMA) account (i.e., username & password): and, the ones already using another EMA application (i.e., Eudralink, SPOR, IRIS, EudraVigilance, OMS) can use the same login information. If one works externally for a sponsor, then permissions must be given by the administrator(s) of this organisation before starting to work in the CTIS workspace.

Sponsors should ensure that the details of the medicinal products used in the CT have already been registered in the eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) – a dictionary that includes all medicinal products authorised in the EU/EEA, as well as products under development. Of course, a placebo can be added manually without pre-registration in the system.

The documents required for a CT application will vary depending on the type of application or notification submitted; but there are three essential sections defined in the CTIS:

(1) Basic forms and the Member-State Concerned (MSC); 

(2) Part I, consisting of CT details (e.g., Protocol, Investigators Brochure, etc.);

(3) Part II, consisting of CT site and investigator details, and practicalities related to recruitment and informed consent.

In case of a multinational CT, the sponsor proposes one member state to be the Reporting Member-State (RMS). The RMS will be responsible to validate if the clinical trial application is complete and within scope of the CTR. If the clinical trial application is valid, the first assessment phase starts, led by the RMS. This is followed by the second part of the assessment, which is made by each individual member state where the CT will take place. All-in-all, it should not take more than 45 days for this assessment process to take place; and a maximum of 91 days from initial CTIS portal validation to final notification. 

In case a medical device is involved in the CT, three possibilities arise: 

(1) the object of the study is one integral product which is a ‘combination’ of a medical device and a medicinal product – particular account shall be taken to the principal mode of action, CTR applies;

(2) the object of the study is a medicinal product however, during the clinical trial medical devices are used without these being the object of the study – CTR applies, and the medical devices used must comply with the medical device regulation (MDR) EU-rules;

(3) the object of the study is two separate products, one “arm” is a medicinal product and the another “arm” is a medical device – in this case, CTR applies to the medicinal product “arm” and medical device conformity assessment EU-rules apply to the other “arm”.

To promote trust in the society and to support innovative and meaningful trials in EU, while at the same time recognising the legitimate economic interests of sponsors, the new regulation recognises that personal data and commercially confidential information (CCI)should be exempted from publication rules. As such, to enable such data protection, the CTIS offers users with the possibility to upload redacted document versions “for publication” and unredacted document versions “not for publication”. 

Even if 2025 seems a faraway date, sponsors are advised to start as soon as possible applying the new CTR, so that by then there are no lingering CTs in need of rescue.

by Catarina Carrão

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Wien, 17.01.2024 – Text: Catarina Carrão EUDAMED: basics The European database on medical devices (EUDAMED) is an information technologysystem being built and implemented by the European Commission