EU-CTR Did you know?

Key insights about the European Union Clinical Trial Regulation 536/2014

If you currently operate or plan to operate clinical trials in Europe, you will be impacted by the European Union Clinical Trial Regulation 536/2014 (EU-CTR), effective January 2022. The new regulation aims to standardize and harmonize interventional clinical trials across the European Economic Area (EEA), with legally binding rules on requirements and increased transparency.

To prepare for the changes, companies will need to mobilize all stakeholders, analyze current business processes, upgrade information technology systems, and restructure operations to avoid disruptions to ongoing and new clinical trials. As we help to mobilize client operations, we've collated some of the most commonly asked questions and provided useful insights from our experts.

Query responses will only have a maximum 12-day turnaround window

Query responses will only have a maximum 12-day turnaround window

This is the maximum time for query response or request for information (RFI) otherwise an application lapses by default...

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.

What does this mean for you?

The Voluntary Harmonization Process (VHP) will be discontinued 3-months prior to go-live

The Voluntary Harmonization Process (VHP) will be discontinued 3-months prior to go-live

From day one of the EU-CTR go-live, any ongoing VHP procedures need to be completed...

This is the last opportunity to achieve a harmonized CTA dossier across EEA countries through a VHP substantial amendment application. Prior to day one of the EU-CTR go-live date on 31-Jan-2022, any ongoing VHP procedures need to be completed.

This means

  • You should evaluate your VHP trial dossiers now for EU-CTR transition readiness and develop a EU-CTR transition strategy, considering the global end of trial date, CTA dossier harmonization status across EEA countries, your organizational readiness and other aspects.
  • After 31-Jan-2022 any ongoing Voluntary Harmonization trials need to either revert to national procedure under Clinical Trials Directive 2001/20/EC, or transition under EU-CTR and get tacit approval before submitting any substantial modifications such as a protocol amendments.

What does this means for you?

All study drug supplies used in EEA countries will need to display “period of use” (expiry or retest date) without any exceptions

All study drug supplies used in EEA countries will need to display “period of use” (expiry or retest date) without any exceptions

Applicable to all clinical trials submitted under EU-CTR or ongoing trials when transitioned to the EU CTR...

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

What does this mean for you?

There is a requirement for a holistic collaborative approach for trial modification planning at trial and country/site level

There is a requirement for a holistic collaborative approach for trial modification planning at trial and country/site level

There are strict rules for modifications under EU-CTR...

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.

What does this mean for you?

A joint Scientific and Ethics Committee evaluation is an integral component of CTIS applications

A joint Scientific and Ethics Committee evaluation is an integral component of CTIS applications

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

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.

What does this mean for you?

There is only a one-year transition period for new trial applications

There is only a one-year transition period for new trial applications

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...

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

What does this mean for you?

Lay summaries will be mandated as part of the EU-CTR

Lay summaries will be mandated as part of the EU-CTR

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...

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.

What does this mean for you?

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