European Union Clinical Trial Regulation 536/2014 (EU CTR) became applicable on January 31, 2022 and has introduced a more centralised approach to clinical trial conduct in the EU, enhanced transparency requirements, and a new GMP framework for Investigational Medicinal Products (IMPs).

Almac Clinical Services is ready to support delivery of your investigational products as you navigate the transition from Directive 2001/20/EC to Regulation 536/2014 and will continue to support the delivery of investigational products in the EU and beyond.

Almac provides industry leading solutions for clinical trials globally, including:

• Global packaging and distribution solutions for all clinical trial designs
• Clinical label services
• QP Release support for EU and UK
• Supply Chain Management
• Temperature Services Management
• Global Depot Network

As the deadline for full implementation of the Clinical Trial Regulation approaches many sponsors are, for the first time, becoming familiar with the processes and adapting accordingly.

As a Sponsor, you must transition any clinical trials that are expected to be ongoing in the EU after 30th January 2025.

In preparation you must consider the time required for Member States to complete the authorisation procedure, which can take up to three months. The EU have advised that applications to transition should be submitted no later than 16th October 2024 to allow for review and authorisation before the final deadline.

Clinical Trials that have not transitioned and been authorised under the EU CTR before the deadline will not be compliant and therefore cannot continue.

As you progress through this transition process, keep your QP Services and/or Project Services contacts informed of the status to avoid any risk to your Clinical Trial(s).