Category | Clinical trial services
The new EU Clinical Trial Regulation (CTR) is intended to simplify clinical trial administration and create a more welcoming climate for pharmaceutical companies that operate in Europe. As the regulation is now legally binding—unifying regulatory, labeling, and Qualified Person (QP) requirements—sponsors need to fully understand its requirements. Read on to learn implications for the drug industry, including routes to compliance, which requires experienced people, the ability to adapt, possibly a partner with expertise in clinical trials, a global footprint, proven technology, and risk mitigation skills.
Despite heated debate along the way, the CTR does not allow electronic labels (eLabels) for investigational drugs for clinical trials. Instead, printed expiry dates must appear on both the immediate and secondary packaging of investigational drugs, based on the traditional booklet label.
The CTR’s labeling requirements focus on the “period of use” indication—the expiry date of an Investigational Medicinal Product (IMP) or an Auxiliary Medicinal Product (AMP). This must appear on the product’s immediate or primary packaging and on its secondary packaging.1
In response to these new requirements, manufacturers have expressed concerns in multiple areas:
The expiry date—or period of use indication—of IMPs or AMPs being supplied for clinical trials must now be shown on the immediate packaging, with no exceptions.2 This is required by Annex VI of the EU Clinical Trial Regulation 536/2014. This has a significant impact on the ability to perform shelf-life extensions and prevents possible use of electronic systems.
The last item on this list, eLabels, can take many forms, several of which can be updated rapidly via the cloud. Examples include the use of barcodes, quick response (QR) codes, radio frequency identification (RFID) tags, and electronic paper that is adhered to the packaging and can be changed (Figure 1).
The basic functionality and benefits of eLabels are shown below.
Benefits of eLabels for patients, sites, regulators, and sponsors, based on the findings of an initiative by TransCelerate—an organization that collaborates across the global biopharma R&D community on topics of common interest—also include the following:3
Earlier efforts to expand eLabel use include a 2020 initiative by a group of seven major drug firms.4 This group, known as the Alliance to Modernize Prescribing Information, argued that paper labeling is outdated and incompatible with the technological flow of patient safety information. Others have pointed out that revisions to approved labels—which are needed an average of five times per year—are time-consuming and may involve a time lag, posing a patient safety risk.5 These arguments are valid, and it may at last be time to embrace eLabels for investigational drugs for clinical trials. One promising approach might be to start deploying electronic solutions on a small scale, in parallel with the required booklet labels, which includes patient information in the languages of all countries where the drug is available. If shown to offer continued, or even superior, protection for patient safety, this might provide the proof of concept needed to build trust among regulators.
However, patient safety must remain front and center at all times as new options are considered.
External partners can help fulfill sponsor needs for labeling compliance support, whether for individual elements to supplement a big pharma company’s own capacity or for a full range of end-to-end packaging and clinical trial services for an emerging biotech. Sponsors looking to partner on labeling advances should evaluate several qualities in potential partners:
Once the hurdle of the updated label requirements is overcome, sponsors can expect to gain the intended benefits of the new CTR, including improved collaboration, information sharing, and decision-making between and within member states.