Even though the final date of submission under the Clinical Trial Directive is end of January, 2023, the start-up of clinical trials in waves requires more time. 

This means:

• Thoughtful and timely planning of country and site-selection to ensure all submissions to Competent Authorities and Ethics Committees for all EEA countries are done prior end of January, 2023.
• Ensure smooth trial conduct after initial approval, not disrupted by adding EEA countries which triggers EU-CTR transition

The EU-CTR require sponsors to perform certain tasks themselves, even if the trial is fully outsourced to a CRO.

This means sponsors need to:

• Define redaction principles and deferral rules
• Obtain EMA account for staff acting as SPOR Industry Super User
• You will need to register for various CTIS admin user roles

Submission of new clinical trial applications will no longer be possible after 31 January 2023 under the EU CT Directive for any EEA country

This means:

• For an ongoing clinical trial under the EU CT Directive, new requests for clinical trial authorizations to include further EEA countries are not possible after 30-January-2023
• To add new EEA countries to an ongoing clinical trial under EU Directive after this date, you must first transition the trial to the EU CTR and then submit additional EEA countries following the EU CTR procedure

IMP labels may need to be updated to display “period of use” on any immediate packaging without exceptions

This means:

• Updates to IMP labels require to happen only to batches that are labeled (or relabeled) after the authorization of the trial under the EU CTR, while not for those batches already released.

There are no separate regulatory or ethics committee (EC) application submissions under the EU-CTR.

This means:

• This could potentially result in more queries to be addressed within the stringent response times.
• There will be aligned considerations between ECs and National Competent Authorities.

Applicable to all clinical trials submitted under EU-CTR or ongoing trials when transitioned to the EU CTR. Label updates are needed for all IMPs and AxMPs.

This means:

• Assess your current label set-up for alignment with EU-CTR requirements for any trials you intend to run under EU-CTR

While this may seem a long time, it really isn’t if you haven’t started aligning your internal structure to the required changes, including people, processes, and technology.

This means:

• If you want to add further countries to ongoing trial under the EU Directive after the first year, this trial will need to be transitioned to the EU-CTR
• Determine a transition plan for both new and existing trials

The option to start a new clinical trial under the EU Clinical Trial Directive rules is only permitted in the first year of the transition period.

This means:

• The initial request for clinical trial authorization for all participating EEA countries must be submitted latest on 30 January 2023, whilst the authorization may be received after this date.
• If such trial continues to be conducted in the European Union from 31 January 2025 onwards, all EEA countries with active sites must be transitioned to the EU CT Regulation latest by 30 January 2025 (authorization date).

There are strict rules for modifications under EU-CTR.

This means:

• All substantial modifications (on studies and individual country/site level) will have to be reviewed and evaluated, and even approved in their entirety.
• If adding unrelated changes to a substantial modification the unacceptability of one component will risk the approval of the entire dossier change.
• Synchronize your operations and regulatory strategy.

As part of the new regulation it is a mandated requirement that plain language lay summaries are to be published on the Clinical Trial Information System (CTIS) no later than 12 months after clinical study close. The CTIS is expected to go live in January 2022.

This means:

• Be prepared in advance of the go-live date.
• Define your lay summary development process including review and approvals.
• Develop your lay summary template, applying careful consideration to the content and visual requirements of lay audiences as well as the technical requirements.

This is the maximum time for query response or request for information (RFI) otherwise an application lapses by default. An RFI window is not flexible, so this means that it will need to be addressed if you have multiple countries and languages.

This means:

• Document revisions including any potential translations and redaction needs will need be available as they need to be included in the response submissions.
• The response time may also be shorter if required.
• An efficient, rapid response RFI response process will be required with simple and easy-to-use templates to allow for easy redaction.